AzTrials
AzTrials

B Acute Lymphoblastic LeukemiaPhase 3NCT03150693

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

A Phase 3 study testing Allopurinol, Cytarabine and Daunorubicin Hydrochloride in people with B Acute Lymphoblastic Leukemia, run by Alliance for Clinical Trials in Oncology at 460 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
B Acute Lymphoblastic Leukemia
What is being tested?
Allopurinol, Cytarabine and Daunorubicin Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
460 sitesin 2 countries
Study dates
20 Sep 2017to 1 Apr 2028
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
  • Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age >= 18 years and < 40 years
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
Show all 19Show fewer
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized
  • Rating: M0, M1; Blast Cells (%): 0-5.0
  • Rating: M2; Blast Cells (%): 5.1-25.0
  • Rating: M3; Blast Cells (%): > 25-50
  • Rating: M4; Blast Cells (%): > 50.0
  • The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) >= 750/mm^3
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count >= 75,000/mm^3
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome
  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

Who cannot join

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 8 days prior to registration is required
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Trial locations and contacts

460 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Daniel J. DeAngelo, MD, PhD contact

617-632-2645

daniel_deangelo@dfci.harvard.edu

305 sites in 2 countries

United States300 sites, 89 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Suspended

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-486-6000

    Craig S. Boddy

    Recruiting

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

    Suspended

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

    Suspended

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Suspended

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

    Suspended

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Active, not recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Suspended

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

    Suspended

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Suspended

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Suspended

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Suspended

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Suspended

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Suspended

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Suspended

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Suspended

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    William G. Blum

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    Vamsi Kota

    Recruiting

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

    Active, not recruiting

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

    Suspended

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Suspended

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Suspended

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Shella Saint Fleur-Lominy

    Recruiting

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

    Active, not recruiting

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

    Active, not recruiting

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

    Active, not recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Suspended

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Krishna Gundabolu

    Recruiting

  • Overlake Medical Center

    Bellevue, Washington, 98004

    Suspended

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Suspended

  • Saint Charles Health System

    Bend, Oregon, 97701

    Suspended

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Healthcare

    Billings, Montana, 59101

    Suspended

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Suspended

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Suspended

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Suspended

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Suspended

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Suspended

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Daniel J. DeAngelo

    Recruiting

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Active, not recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Suspended

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Eunice S. Wang

    Recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Suspended

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Suspended

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Suspended

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

    Suspended

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Active, not recruiting

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Suspended

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

    Suspended

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

    Active, not recruiting

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Suspended

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Daniel R. Richardson

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

    Active, not recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Shira N. Dinner

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Melissa L. Larson

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    John G. Quigley

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Wendy Stock

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Emily K. Curran

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Suspended

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Brenda W. Cooper

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Anjali S. Advani

    Recruiting

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

    Suspended

  • Community Cancer Institute

    Clovis, California, 93611

    Site Public Contact, 559-387-1827

    Mohammed S. Bukari

    Recruiting

  • University Oncology Associates

    Clovis, California, 93611

    Suspended

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Suspended

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Meixiao Long

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Suspended

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Suspended

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627

    Site Public Contact, 877-827-8839

    Deepa Jeyakumar

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Suspended

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

    Suspended

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

    Suspended

  • The Women's Imaging Center

    Denver, Colorado, 80209

    Active, not recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Active, not recruiting

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

    Active, not recruiting

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

    Suspended

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

    Active, not recruiting

  • Rose Medical Center

    Denver, Colorado, 80220

    Suspended

  • Western Surgical Care

    Denver, Colorado, 80220

    Active, not recruiting

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

    Active, not recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Active, not recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Active, not recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Active, not recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

    Active, not recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 800-527-6266, ctoadmin@karmanos.org

    Jay Yang

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Suspended

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Suspended

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Jennifer M. Suga

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Suspended

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Suspended

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Suspended

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Suspended

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Suspended

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Suspended

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

    Active, not recruiting

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

    Active, not recruiting

  • Swedish Medical Center

    Englewood, Colorado, 80113

    Suspended

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Active, not recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Suspended

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    Suspended

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Active, not recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Active, not recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Suspended

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Jay Yang

    Recruiting

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

    Suspended

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Active, not recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Suspended

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Suspended

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

    Suspended

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Fresno Cancer Center

    Fresno, California, 93720

    Suspended

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Suspended

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

    Suspended

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

    Suspended

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Suspended

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

    Suspended

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Darla K. Liles

    Recruiting

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

    Suspended

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Ki Y. Chung

    Recruiting

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Suspended

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

    Suspended

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Suspended

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

    Suspended

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

    Suspended

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

    Suspended

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Suspended

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • Island Urology-Hilo

    Hilo, Hawaii, 96720

    Suspended

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Site Public Contact, 954-265-1847, OHR@mhs.net

    Fernando M. Vargas Madueno

    Recruiting

  • Loyola Medicine Homer Glen

    Homer Glen, Illinois, 60491

    Suspended

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

    Suspended

  • Island Urology

    Honolulu, Hawaii, 96813

    Suspended

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

    Suspended

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Suspended

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-522-4333

    Craig S. Boddy

    Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Suspended

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

    Suspended

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

    Suspended

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Suspended

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

    Suspended

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

    Suspended

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Craig S. Boddy

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-790-2700

    Siddhartha Ganguly

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Grerk Sutamtewagul

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Deepa Jeyakumar

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Suspended

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

    Suspended

  • Freeman Health System

    Joplin, Missouri, 64804

    Suspended

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Suspended

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

    Suspended

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

    Suspended

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Kenneth Byrd

    Recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Suspended

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Suspended

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Suspended

  • Good Samaritan Hospital - Cancer Centers of Colorado

    Lafayette, Colorado, 80026

    Suspended

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Active, not recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Bradley H. Goldberg

    Recruiting

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

    Active, not recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Suspended

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

    Suspended

  • Desert West Surgery

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Suspended

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

    Suspended

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

    Suspended

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

    Suspended

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

    Suspended

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

    Suspended

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

    Suspended

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

    Suspended

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

    Suspended

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

    Suspended

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

    Suspended

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

    Suspended

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Suspended

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

    Suspended

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

    Suspended

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

    Suspended

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

    Suspended

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Suspended

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

    Suspended

  • University Cancer Center

    Las Vegas, Nevada, 89169

    Suspended

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Suspended

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Ayman Qasrawi

    Recruiting

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

    Suspended

  • Rush MD Anderson Cancer Center at Rush Lisle

    Lisle, Illinois, 60532

    Suspended

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

    Active, not recruiting

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

    Suspended

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting

  • Logan Regional Hospital

    Logan, Utah, 84321

    Suspended

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

    Active, not recruiting

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

    Suspended

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

    Suspended

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

    Suspended

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

    Active, not recruiting

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

    Suspended

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Ryan J. Mattison

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Ryan J. Mattison

    Recruiting

  • North Shore University Hospital

    Manhasset, New York, 11030

    Site Public Contact, 516-734-8896

    Bradley H. Goldberg

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Suspended

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Suspended

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Suspended

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

    Suspended

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Patrick A. Hagen

    Recruiting

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

    Suspended

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

    Suspended

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Suspended

  • Miami Cancer Institute

    Miami, Florida, 33176

    Active, not recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Guru Subramanian Guru Murthy

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Suspended

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

    Suspended

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

    Suspended

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente- Modesto MOB II

    Modesto, California, 95356

    Site Public Contact, 877-642-4691

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

    Suspended

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Suspended

  • Intermountain Medical Center

    Murray, Utah, 84107

    Suspended

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Suspended

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Tareq Al baghdadi

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Suspended

Other trials in United States

Canada5 sites, 2 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Suspended

  • QEII Health Sciences Centre/Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

    Site Public Contact, 902-473-6000

    Nicholas A. Forward

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Suspended

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

    Site Public Contact, 613-761-4395

    Jill Fulcher

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Suspended

Other trials in Canada

About this study

Official title: A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) III. To determine the safety and tolerability of a reduced dose of inotuzumab ozogamicin and two cycles of blinatumomab added to the pediatric-inspired regimen of CALGB 10403 (Pilor cohort).

SECONDARY OBJECTIVES:

  1. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant.

III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.

IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen.

  1. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403.

CORRELATIVE SCIENCE OBJECTIVES:

  1. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature.

II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, sex and age at diagnosis.

III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm.

IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS.

  1. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population.

VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study [GWAS]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS.

VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes.

VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity.

IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence.

  1. To determine the impact of adherence on risk of relapse among AYAs with ALL. XI. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

XII. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated on this protocol.

XIII. To correlate specific karyotype groups with MRD. XIV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse.

XV. To define the rate, analytical performance, and diagnostic yield of ChromoSeq vs. conventional G-banded karyotyping and fluorescence in situ hybridization (FISH) for B ALL patients in a multicenter setting.

OUTLINE:

COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously, over 1 to 30 minutes (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegaspargase for patients >21.5 years IV, over 1 to 2 hours on day 4, 5, or 6, or calaspargase pegol IV, over 1 hour, on days 4, 5 or 6 and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29.

Patients enrolled prior to Update 8 with response to remission induction therapy are randomized to 1 of 2 arms. Patients enrolled after amendment 8 are assigned to the pilot cohort. Patients with no response are omitted from the study.

ARM I (CLOSED 7/23/2025):

COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes on days 15, 22, 43, and 50. Patients >21.5 years also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients <21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive radiation therapy (RT). Patients who are MRD+ and CD19+ after completion of this course receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 56.

COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11.

COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients <21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV.

COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity.

Patients undergo multigated acquisition scan (MUGA) or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

ARM II (CLOSED 7/23/2025): Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.

Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

PILOT COHORT: Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28.

COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes, on days 15, 22, 43, and 50. Patients > 21.5 years old also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour, on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20+ patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive RT. Patients then undergo bone marrow aspirate and biopsy on day 56.

BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42.

COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11.

BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42. Patients who are MRD positive and CD19+ after Course II may continue to receive blinatumomab IV, continuously on days 1-28 of each cycle. Cycles repeat every 42 days for an additional 2 cycles in the absence of disease progression or unacceptable toxicity, per investigator discretion.

COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients > 21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients < 21.5 years old receive calaspargase pegol IV, over 1 hour, on day 4, 5, or 6 and 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV.

COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT on day 1 of cycles 1-4 and PO once weekly (QW) of each cycle. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity.

Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 2 months for 2 years, every 3 months 2 years, and then every 6 months for up to 10 years.

Being tested
Allopurinol, Cytarabine, Daunorubicin Hydrochloride, Vincristine Sulfate, Dexamethasone
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AllopurinolDrug

    Given PO

  • CytarabineDrug

    Given IT, IV, SC

  • Daunorubicin HydrochlorideDrug

    Given IV

  • Vincristine SulfateDrug

    Given IV

  • DexamethasoneDrug

    Given PO or IV

  • Pegylated L-AsparaginaseDrug

    Given IV

  • MethotrexateDrug

    Given IT, IV, PO

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow aspiration and biopsy

  • CyclophosphamideDrug

    Given IV

  • MercaptopurineDrug

    Given PO

  • RituximabBiological

    Given IV

  • DoxorubicinDrug

    Given IV

  • ThioguanineDrug

    Given PO

  • Inotuzumab OzogamicinBiological

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03150693
Study groupRoleWhat they receive
Arm I (frontline chemotherapy)Active comparatorSee detailed description.
Receives: Drug: Allopurinol; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Vincristine Sulfate; Drug: Dexamethasone; Drug: Pegylated L-Asparaginase; Drug: Methotrexate; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Mercaptopurine; Biological: Rituximab; Drug: Thioguanine; Other: Laboratory Biomarker Analysis
Arm II (frontline chemotherapy, inotuzumab ozogamicin)ExperimentalPatients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.
Receives: Drug: Allopurinol; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Vincristine Sulfate; Drug: Dexamethasone; Drug: Pegylated L-Asparaginase; Drug: Methotrexate; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Mercaptopurine; Biological: Rituximab; Drug: Doxorubicin; Drug: Thioguanine; Biological: Inotuzumab Ozogamicin; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    The EFS distributions between the two arms will be compared using non-stratified log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. with diagnostics test on proportional hazard assumptions first. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.

    Measured: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years

Secondary outcomes (7)

  1. Disease-free survival (DFS)

    Measured: Time from achievement of complete response (CR) to the time of relapse and/or death, assessed up to 10 years

  2. Overall Survival (OS)

    Will be evaluated using Kaplan-Meier as well as Cox regression models.

    Measured: Time from randomization to the time of death due to any cause, assessed up to 10 years

  3. Proportion of patients who achieve CR or any response to induction therapy

    Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.

    Measured: Up to 10 years

  4. Overall induction response rates

    Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.

    Measured: Up to 10 years

  5. Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0

    The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.

    Measured: Up to 10 years

  6. Proportion of patients who go off treatment due to adverse reactions

    Will be assessed within each of the treatment arms and differences explores in these measures between the arms.

    Measured: Up to 10 years

  7. Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial

    Will be assessed within each of the treatment arms and differences explores in these measures between the arms.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study start20 Sep 2017
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150693
Sponsor's protocol ID
A041501
Other IDs
NCI-2016-01981, U10CA180821
Status last verified
Oct 2026
First submitted
9 May 2017
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

  • Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.

    PubMed 32589970

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