AzTrials
AzTrials

Recurrent Adult Lymphoblastic LymphomaPhase 1/2NCT03504644

Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Lumbar Puncture in people with Recurrent Adult Lymphoblastic Lymphoma and Recurrent B Acute Lymphoblastic Leukemia, run by ECOG-ACRIN Cancer Research Group at 170 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Lumbar Puncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
170 sitesin 2 countries
Study dates
13 Aug 2018to 31 Dec 2028
Phase
Phase 1/2

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 0: Patient must be considered a potential candidate for the trial
  • NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration; bone marrow and/or peripheral blood specimens collected during Step 0 or prior to treatment on Step 1 must be submitted for central review in order for the patient to be considered evaluable; results will not be reported to the site and will not impact patient participation in the trial
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must have a diagnosis of:
  • Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy
  • Patients with < 5% blasts may enroll on trial in phase I portion provided that minimal residual disease (MRD) is present at > 10^-3 as tested on an assay with minimum sensitivity of 10^-4 OR
  • Relapsed lymphoblastic lymphoma
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  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Age >= 18 years
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Circulating white blood cell (WBC) count must not be above 25 x 10^9/L at the time of registration
  • Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Glomerular filtration rate (GFR) of at least 40 mL/min within 7 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: All patients of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG) within 2 weeks prior to registration to rule out pregnancy
  • A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not expect to conceive or father children by using accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax
  • Should a patient or a partner of a patient become pregnant or suspect they are pregnant while participating in the study, the treating physician should be notified immediately
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: No evidence of prior solid malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 2 years so as not to interfere with interpretation of radiographic response
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of registration to step 1; patient must be off immunosuppression and without active graft versus host disease (GVHD) prior to registration to step 1 if previous HSCT
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 0: Patient must be considered a potential candidate for the trial
  • NOTE: Enrollment to Step 0 may occur prior to or following completion of the assessments to verify patient eligibility for Step 1 registration
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Relapsed or refractory B-cell or T-cell ALL, including lymphoblastic lymphoma, after at least one line of chemotherapy
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Age >= 18 years
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: ECOG performance status 0-2
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Adequate liver function with AST/ALT less than 3 x upper limit of normal and total bilirubin less than 2 mg/dL within 10 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Circulating WBC count must not be above 25 x 10^9/L at the time of registration to step 1
  • Patients with WBC count above 25 x 10^9/L are eligible if they have started steroids or hydroxyurea per institutional guidelines
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: GFR of at least 40 mL/min within 7 days prior to first dose of study agent
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: All patients of childbearing potential must have a blood test or urine study with a minimum sensitivity 25 IU/L or equivalent units of HCG within 2 weeks prior to registration to rule out pregnancy.
  • A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not expect to conceive or father children by using accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax
  • Should a patient or partner of a patient become pregnant or suspect she is pregnant while participating in this study, the treating physician should be informed immediately
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active GVHD prior to enrollment if previous HSCT. Low-dose steroids (10mg or less) are allowed

Who cannot join

  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients of childbearing potential must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with isolated testicular or central nervous system (CNS) relapsed disease are not eligible
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have Burkitt's lymphoma/leukemia based on the World Health Organization (WHO) criteria
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients will not be enrolled if they received prior chemotherapy within 2 weeks before registration to step 1 with the following exceptions: to reduce the circulating lymphoblast count or palliation or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients cannot have poorly controlled chronic viral infections including hepatitis B, C, or human immunodeficiency virus (HIV); HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
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  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not be taking any other experimental medications within 21 days prior to registration. Clinical trial medications that are Food and Drug Administration (FDA) approved will be allowed within 14 days prior to registration
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients should not have received the following within 7 days prior to the first dose of study drug:
  • Strong and moderate CYP3A inhibitors;
  • Strong and moderate CYP3A inducers
  • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy or history of grade 3 or higher peripheral neuropathy. Patients with familial demyelinating disease like Charcot-Marie-Tooth disease are also excluded
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with prior venetoclax treatment for ALL will be excluded
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical or breast carcinoma, or chemotherapy-surgically- or radiation-cured malignancy continuously disease free for >= 2 years
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with isolated testicular or CNS relapsed disease are not eligible
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have Burkitt's lymphoma/leukemia based on the WHO criteria
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed and once cleared, prophylactic intrathecal chemotherapy can be continued
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients cannot have poorly controlled chronic viral infections including hepatitis B, C, or HIV; HIV positive patients with undetectable viral load are allowed
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have received the following within 7 days prior to the first dose of study drug or while on study treatment:
  • Strong and moderate CYP3A inhibitors;
  • Strong and moderate CYP3A inducers
  • ELIGIBILITY CRITERIA - PHASE II (ARM D) - STEP 1: Patients must not have grade 3 or higher peripheral neuropathy or history of grade 3 peripheral neuropathy; patients with familial demyelinating diseases like Charcot-Marie-Tooth disease also excluded

Trial locations and contacts

170 sites in 2 countries.

170 sites in 2 countries

United States163 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Loyola Medicine Homer Glen

    Homer Glen, Illinois, 60491

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

Other trials in United States

Puerto Rico7 sites

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

  • Doctors Cancer Center

    Manati, 00674

  • San Juan Community Oncology Group

    San Juan, 00917

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • PROncology

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine or Vincristine Sulfate in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, 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 venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose of venetoclax in combination with vincristine liposomal (liposomal vincristine)/vincristine sulfate in patients with relapsed or refractory T-cell and B-cell acute lymphoblastic leukemia (ALL). (Phase I) II. Safety assessment and toxicity characterization after treatment of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL. (Phase I) III. To determine the preliminary efficacy of venetoclax in combination with liposomal vincristine/vincristine sulfate to induce complete remission (CR)+ incomplete complete remission (CRi) in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II)

SECONDARY OBJECTIVES:

  1. To determine the progression free survival, overall survival and toxicity after the combination treatment in patients with relapsed or refractory T-cell and B-cell ALL. (Phase II) II. To determine the rate of minimal residual disease (MRD) negativity rate of the combination. (Phase II)

EXPLORATORY/CORRELATIVE OBJECTIVES:

  1. To determine if genetic signature as determined by next generation sequencing can predict response to combination. (Phase II) II. To determine if immunophenotype of ALL is associated with response to combination. (Phase II) III. To determine if the BH3 profile is associated with response to combination. (Phase II) IV. To determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination. (Phase II)

OUTLINE: This is a phase Ib, dose-escalation study of venetoclax followed by a phase II study.

PHASE Ib: Patients receive venetoclax orally (PO) once daily (QD) on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal intravenously (IV) over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo computed tomography (CT) and/or positron emission tomography (PET) scan as well as a lumbar puncture as clinically indicated.

PHASE II: Patients receive venetoclax PO QD on days 1-28 of each cycle. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks on day 1 of each cycle or vincristine sulfate IV weekly on days 1, 8, 15, and 22 of cycle 1 and once every 4 weeks on day 1 of each subsequent cycle. Cycles repeat every 28 days. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Being tested
Biospecimen Collection, Computed Tomography, Lumbar Puncture, Positron Emission Tomography, Venetoclax
Keywords
Venetoclax, Liposomal Vincristine, Vincristine Sulfate, Acute Lymphoblastic Leukemia, T-cell, B-cell, Phase Ib/II
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Lumbar PunctureProcedure or surgery

    Also called LP, Spinal Tap

    Undergo lumbar puncture

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • VenetoclaxDrug

    Also called ABT 199, ABT-0199, ABT-199, ABT199

    Given PO

  • Vincristine LiposomalDrug

    Also called Lipid-Encapsulated Vincristine, Liposomal Vincristine, Onco TCS, Vincacine

    Given IV

  • Vincristine SulfateDrug

    Also called Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin

    Given IV

Study groups in NCT03504644
Study groupRoleWhat they receive
Phase Ib (venetoclax, vincristine liposomal)ExperimentalPatients receive venetoclax PO QD on days 1-42 of cycle 1 and days 43-70 of cycle 2. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks starting on day 15 of cycle 1. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lumbar Puncture; Procedure: Positron Emission Tomography; Drug: Venetoclax; Drug: Vincristine Liposomal
Phase II (venetoclax, vincristine liposomal/sulfate)ExperimentalPatients receive venetoclax PO QD on days 1-28 of each cycle. Patients also receive vincristine liposomal IV over 1 hour weekly for 4 weeks on day 1 of each cycle or vincristine sulfate IV weekly on days 1, 8, 15, and 22 of cycle 1 and once every 4 weeks on day 1 of each subsequent cycle. Cycles repeat every 28 days. Patients who achieve at least a stable disease response may continue treating at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the trial. Patients may also undergo CT and/or PET scan as well as a lumbar puncture as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lumbar Puncture; Procedure: Positron Emission Tomography; Drug: Venetoclax; Drug: Vincristine Liposomal; Drug: Vincristine Sulfate

What is being measured

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

  1. Number of Participants With Dose Limiting Toxicity (Phase I)

    A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until > 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If < two (2) patients experience a DLT in Arm C, then the Arm C dose would be considered the MTD.

    Measured: From start of treatment up to 42 days

  2. Number of Participants With Treatment-Related Toxicities (Phase I)

    Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 6 years and 11 months

  3. Complete Remission (CR) + Complete Remission Incomplete (CRi) Rate (Phase II)

    CR+CRi rate (for the best overall response) by the end of cycle 3. A 90% confidence interval will be computed. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf.

    Measured: Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days)

Secondary outcomes (4)

  1. Progression Free Survival (PFS) (Phase II)

    From study registration to documented disease progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method, and the median PFS along with its corresponding 95% confidence interval will be reported. Progressive disease is defined as a 50% increase in blasts in the marrow. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 [updated May 15 2019]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf.

    Measured: While on treatment and every 6 months during follow-up if discontinued for reasons other than PD, up to 5 years from study registration

  2. Overall Survival (OS) (Phase II)

    From study registration to death from any cause. OS will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported.

    Measured: While on treatment and every 6 months during follow-up, up to 5 years from study registration

  3. Incidence of Toxicities (Phase II)

    Toxicity incidences will be assessed and graded according to the CTCAE and will be tabulated by patient cohort.

    Measured: Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years

  4. Minimal Residual Disease (MRD) Negativity Rate (Phase II)

    The MRD response reported here was based on the local assessment (i.e., by site) and met the criteria per protocol: "An MRD negative response must meet the criteria for CR or CRi and have any residual disease <0.01% based on original testing technique."

    Measured: Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days)

Timeline

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

  1. First posted20 Apr 2018
  2. Study start13 Aug 2018
  3. Primary completion22 Jul 2025
  4. Study completion31 Dec 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504644
Sponsor's protocol ID
EA9152
Other IDs
NCI-2017-01158, EA9152, EA9152, U10CA180820
Status last verified
Sep 2026
First submitted
12 Apr 2018
Last updated
6 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Publications

  • Palmisiano ND, Lee JW, Claxton DF, Paietta EM, Alkhateeb H, Park J, Podoltsev NA, Atallah EL, Schaar DG, Dinner SN, Webster JA, Luger SM, Litzow MR. A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia: Results from the ECOG-ACRIN EA9152 protocol. EJHaem. 2024 Aug 8;5(5):951-956. doi: 10.1002/jha2.991. eCollection 2024 Oct.

    PubMed 39415930

  • Neil Palmisiano, Juwhei Lee, David Claxton, Elisabeth Paietta, Nikolai Podoltsev, Jae Park, Dale Schaar, Jonathan Webster, Selina Luger, Mark Litzow; Phase II Results of ECOG-ACRIN EA9152: A multicenter study of liposomal vincristine (L-VCR) or vincristine sulfate (VCR) and venetoclax (VEN) in relapsed or refractory acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LL). Blood 2025; 146 (Supplement 1): 1577. doi: https://doi.org/10.1182/blood-2025-1577

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