AzTrials
AzTrials

LeukemiaNCT00096135

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

A study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by Children's Oncology Group at 153 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 months to 29 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, cyclophosphamide and cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
153 sitesin 5 countries
Study dates
Nov 2004to Sep 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 months to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
  • In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
  • First isolated CNS and/or testicular relapse
  • Isolated CNS relapse, as defined by 1 of the following:
  • WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
  • Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
  • Identifiable blasts AND 1 of the following:
  • B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
  • T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
  • Isolated testicular relapse, defined as biopsy proven testicular involvement
  • No Down syndrome
  • No T-cell ALL or T-cell non-Hodgkin lymphoma
  • No known optic nerve and/or retinal involvement

PATIENT CHARACTERISTICS:

Age

  • 18 months to 29 years at relapse

Performance status

  • Karnofsky 30-100% (for patients > 16 years of age) OR
  • Lansky 30-100% (for patients ≤ 16 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine adjusted according to age as follows:
  • No greater than 0.4 mg/dL (≤ 5 months)
  • No greater than 0.5 mg/dL (6 months -11 months)
  • No greater than 0.6 mg/dL (1 year-23 months)
  • No greater than 0.8 mg/dL (2 years-5 years)
  • No greater than 1.0 mg/dL (6 years-9 years)
  • No greater than 1.2 mg/dL (10 years-12 years)
  • No greater than 1.4 mg/dL (13 years and over [female])
  • No greater than 1.5 mg/dL (13 years to 15 years [male])
  • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

  • Shortening fraction ≥ 27% by echocardiogram OR
  • Ejection fraction ≥ 50% by MUGA

Other

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow transplantation

Chemotherapy

  • Prior total anthracycline dosage ≤ 360 mg/m^2

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior systemic therapy for concurrent extramedullary relapse

Trial locations and contacts

153 sites in 5 countries.

153 sites in 5 countries

United States135 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308-1062

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Texas Tech University Health Sciences Center School of Medicine - Amarillo

    Amarillo, Texas, 79106

  • C.S. Mott Children's Hospital at University of Michigan Medical Center

    Ann Arbor, Michigan, 48109-0286

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia, 30322

  • Children's Hospital Center for Cancer and Blood Disorders

    Aurora, Colorado, 80045

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712-6297

  • Floating Hospital for Children at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201-5493

  • Maimonides Cancer Center at Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • T.C. Thompson Children's Hospital

    Chattanooga, Tennessee, 37403

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106-5000

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205-2696

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Dayton Children's - Dayton

    Dayton, Ohio, 45404-1815

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Southern California Permanente Medical Group

    Downey, California, 90027

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503-2560

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030-2399

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-5381

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89109-2306

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40232

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Midwest Children's Cancer Center at Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Overlook Hospital

    Morristown, New Jersey, 07962

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Keyser Family Cancer Center at Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital and Research Center Oakland

    Oakland, California, 94609

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 95798

  • Advocate Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-9786

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon, 97227

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Carilion Medical Center for Children at Roanoke Community Hospital

    Roanoke, Virginia, 24014

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229-3993

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99220-2555

  • Simmons Cooper Cancer Institute

    Springfield, Illinois, 62794-9677

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794-9446

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • St. Joseph's Cancer Institute at St. Joseph's Hospital

    Tampa, Florida, 33607

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • New York Medical College

    Valhalla, New York, 10595

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada12 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre Hospitalier Universitaire de Quebec

    Québec, G1V 4G2

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, 1205

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, 1011

Other trials in Switzerland

New Zealand2 sites

  • Starship Children's Health

    Auckland, 1

  • Christchurch Hospital

    Christchurch, 8140

Other trials in New Zealand

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

About this study

Official title: Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
  • Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
  • Determine the toxicity of these regimens in these patients.

Secondary

  • Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
  • Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
  • Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
  • Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.

OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).

  • Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.

NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.

NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.

In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.

Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.

  • Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.

Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.

  • Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.

NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.

  • Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
  • Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.

NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.

  • Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.

Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.

  • Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
  • Maintenance therapy for isolated testicular relapse:
  • (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
  • (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.

Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.

All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.

Patients are followed for survival.

Conditions
Leukemia
Being tested
filgrastim, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
Keywords
recurrent childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • filgrastimBiological

    Also called Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen

    given subcutaneously (SC)

  • cyclophosphamideDrug

    Also called CYTOXAN, NSC #26271

    IV over 15-30 minutes

  • cytarabineDrug

    Also called Cytosine arabinoside, Ara-C, Cytosar, NSC #6387

    IV over 3 hours twice daily

  • daunorubicin hydrochlorideDrug

    Also called Daunomycin, rubidomycin, Cerubidine, NSC #82151

    IV over 15 minutes

  • dexamethasoneDrug

    Also called Decadron, Hexadrol, Dexone, Dexameth

    oral twice daily

  • etoposideDrug

    Also called VePesid, Etopophos, VP-16, NSC #141540

    IV over 1 hour

  • leucovorin calciumDrug

    Also called LCV, Wellcovorin, citrovorum factor, folinic acid

    rescue IV over 24 hours

  • mercaptopurineDrug

    Also called 6-MP, Purinethol, 6-mercaptopurine, NSC #000755

    oral

  • methotrexateDrug

    Also called MTX, amethopterin, Trexall, NSC #000740

    intramuscularly (IM)

  • pegaspargaseDrug

    Also called PEG-asparaginase, PEGLA, PEG-L-asparaginase, polyethylene glycol-L-asparaginase

    intramuscularly (IM)

  • therapeutic hydrocortisoneDrug

  • vincristine sulfateDrug

    Also called Oncovin, VCR, LCR, NSC #67574

    given IV

  • radiation therapyRadiation

    Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.

Study groups in NCT00096135
Study groupRoleWhat they receive
CNS Patients-Treatment (combination chemotherapy)ExperimentalAll patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Radiation: radiation therapy
Testicular Relapse Patients (Combination chemotherapy)ExperimentalAll patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: therapeutic hydrocortisone; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

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

  1. Event-free Survival

    Monitoring of efficacy results will be performed in comparison with historical results.

    Measured: 3 years

Timeline

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

  1. First posted9 Nov 2004 (estimated)
  2. Study startNov 2004
  3. Primary completionSep 2013

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096135
Sponsor's protocol ID
AALL02P2
Other IDs
COG-AALL02P2, NCI-2011-01623
Status last verified
Feb 2017
First submitted
9 Nov 2004
Last updated
21 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by Children's Oncology Group at 153 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Canada, Switzerland, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.

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