AzTrials
AzTrials

LeukemiaPhase 3NCT00005585

Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

A Phase 3 study testing cyclophosphamide, cytarabine and daunorubicin hydrochloride in people with Leukemia, run by Children's Oncology Group at 123 sites in 6 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia. Read more about this study

Who is it for?
Ages 1 year to 9 years
Conditions the study is for
Leukemia
What is being tested?
cyclophosphamide, cytarabine and daunorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
838 participants
Where
123 sitesin 6 countries
Study dates
Apr 2000to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

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 1 year to 9 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell precursor acute lymphoblastic leukemia
  • Registered on POG-9900 Classification Study
  • Registered within 7 days of documenting complete response (CR) after induction therapy on day 29 or, if 2 more weeks of induction are required, within 7 days of CR determination
  • Classified as low-risk:
  • WBC less than 50,000/mm^3
  • Age 1 to 9
  • No adverse translocations [E2A-PBX1, t(1;19) or BCR/ABL, t(9;22); and MLL rearrangements]
  • No CNS 3 disease (CSF WBC at least 5/mm^3 with blasts present)
  • No testicular disease
  • At least one of the following present:
  • TEL/AML1, t(12;21)
  • Simultaneous trisomy of chromosomes 4 and 10

PATIENT CHARACTERISTICS:

Age:

  • 1 to 9

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Trial locations and contacts

123 sites in 6 countries.

123 sites in 6 countries

United States108 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

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

    Atlanta, Georgia, 30342

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-4000

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-7223

  • Pediatric Specialty Clinic at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114-2696

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    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

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78466

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

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

    Dallas, Texas, 75390-9063

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

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

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

    Houston, Texas, 77030-2399

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37614-0622

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

    Kansas City, Kansas, 66160-7357

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2511

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

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

    Little Rock, Arkansas, 72205

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 30101

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36604

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8064

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Beth Israel Medical Center - Singer Division

    New York, New York, 10128

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Stanford Cancer Center at Stanford University Medical Center

    Palo Alto, California, 94304-1812

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

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

    Portland, Oregon, 97227

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0121

  • Carilion Medical Center for Children at Roanoke Community Hospital

    Roanoke, Virginia, 24029

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

    Rochester, New York, 14642

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • MBCCOP - South Texas Pediatrics

    San Antonio, Texas, 78229-3900

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051-5386

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Walter Reed Army Medical Center

    Silver Spring, Maryland, 20910

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11794-8174

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-0001

  • St. Joseph's Children's Hospital of Tampa

    Tampa, Florida, 33677-4227

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

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

    West Palm Beach, Florida, 33407

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Canada8 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8S 4J9

  • Montreal Children's Hospital at McGill University Health Center

    Montreal, Quebec, H3G 1A4

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Australia3 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland2 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

Other trials in Switzerland

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

About this study

Official title: ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy and toxicity of short methotrexate infusion vs longer infusion in patients with low-risk acute lymphoblastic leukemia.
  • Compare the efficacy of these regimens of methotrexate, with or without multidrug intensification, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to genetics (stratum 1: trisomy 4/10 but not TEL/AML1 vs stratum 2: TEL/AML1 with or without trisomy 4/10).

All patients receive induction therapy (weeks 1-4) on another protocol (POG-9900).

Stratum 1

  • Consolidation therapy begins on week 5. Patients are randomized to arm I or II.
  • Arm I: Patients receive methotrexate (MTX) IV over 24 hours on day 1 and oral leucovorin calcium (CF) every 6 hours for 3 doses beginning 42 hours after initiation of MTX infusion during weeks 7, 10, 13, 16, and 19.
  • Arm II: Patients receive MTX IV over 4 hours on day 1 and oral CF as in arm I during weeks 7, 10, 13, 16, and 19.
  • Patients in arms I and II also receive MTX intrathecally (IT) on weeks 7, 10, 13, 16, 19, and 22; oral mercaptopurine (6-MP) daily on weeks 5-24; oral dexamethasone (DM) twice daily on days 1-7 of weeks 8 and 17; and vincristine (VCR) IV on day 1 of weeks 8, 9, 17, and 18.

Stratum 2

  • Consolidation therapy begins on week 5 and delayed intensification therapy begins on week 16. Patients are randomized to delayed intensification or no delayed intensification. Patients randomized to no delayed intensification are then randomized to consolidation therapy on arm I or II. Patients randomized to delayed intensification are then randomized to arm III or IV. Patients with trisomy 4/10 are not randomized to arms III and IV.
  • Arm III: Patients receive MTX IV and CF as in arm I on weeks 7, 10, 13, 24, 27, and 30.
  • Arm IV: Patients receive MTX IV and CF as in arm II on weeks 7, 10, 13, 24, 27, and 30.
  • Patients in arms III and IV also receive oral 6-MP daily on weeks 5-13 and then beginning on week 24 and continuing until the end of consolidation; MTX IT on weeks 7, 10, 13, 16, 20, 21, and 30; oral DM twice daily on days 1-7 of weeks 8, 16-18, and 28; VCR IV on day 1 of weeks 8, 9, 16-18, 28, and 29; pegaspargase intramuscularly on week 16; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV on day 1 of week 20; cytarabine IV or subcutaneously on days 2-5 of weeks 20 and 21; and oral thioguanine daily on days 1-14 of weeks 20 and 21.

All patients then receive continuation therapy beginning on week 25 for arms I and II and week 33 for arms III and IV and continuing until week 130 for all arms.

Continuation

  • Arms I and II: Patients receive oral 6-MP daily on weeks 25-130; oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 25, 41, 57, 73, 89, and 105; oral MTX weekly on weeks 25-130 (except during weeks of IT MTX); and MTX IT on weeks 25, 37, 49, 61, 73, 85, 97, and 109.
  • Arms III and IV: Patients receive oral 6-MP daily on weeks 33-130; oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41, 57, 73, 89, and 105; oral MTX weekly on weeks 33-130 (except during weeks of IT MTX); and MTX IT on weeks 37, 49, 61, 73, 85, 97, and 109.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total 902 patients will be accrued for this study within 3.22 years.

Conditions
Leukemia
Being tested
cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, leucovorin calcium
Keywords
childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia

What participants receive

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

  • cyclophosphamideDrug

    Also called Cytoxan, NSC #26271

    Given IV

  • cytarabineDrug

    Also called cytosine arabinoside, Ara-C, Cytosar, NSC #063878

    Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.

  • daunorubicin hydrochlorideDrug

    Also called Daunomycin, rubidomycin, Cerubidine, NSC #82151

    Given IV

  • dexamethasoneDrug

    Also called Decadron, NSC#034521

    Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.

  • leucovorin calciumDrug

    Also called LCV, Wellcovorin, citrovorum factor, folinic acid

    Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)

  • mercaptopurineDrug

    Also called 6-MP, Purinethol, NSC #00075

    An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine

  • methotrexateDrug

    Also called MTX, amethopterin, NSC#00740, IND#4291

    A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis

  • pegaspargaseDrug

    Also called E Coli, Elspar, asparaginase, Erwinia

    E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.

  • thioguanineDrug

    Also called 6-thioguanine, 2-amino-1, 7-dihydro-6H-purine-6-thione, WR-1141

    Given orally

  • vincristine sulfateDrug

    Also called Oncovin, VCR, LCR, NSC #67574

    Given IV

Study groups in NCT00005585
Study groupRoleWhat they receive
Arm I: (combination chemotherapy)ExperimentalCONSOLIDATION: Pts receive Methotrexate(MTX) IV over 24 hrs on day 1 and oral leucovorin calcium (CF) every 6 hrs for 3 doses at 42 hours after initiation of MTX infusion during weeks 7, 10, 13, 16, and 19. Pts also receive MTX IT on wks 7, 10, 13, 16, 19, and 22; oral mercaptopurine(6-MP) daily wks 5-24; oral dexamethasone (DM) 2x on days 1-7 of wks 8 and 17; and vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 17, and 18. CONTINUATION: Pts receive oral 6-MP daily on wks 25-130; oral DM twice a day on days 1-7 and vincristine sulfate (VCR) IV on days 1 and 8 during wks 25, 41, 57, 73, 89, and 105; oral MTX on wks 25-130 (except during wks of IT MTX); and MTX IT on wks 25, 37, 49, 61, 73, 85, 97, and 109.
Receives: Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate
Arm II (combination chemotherapy)ExperimentalCONSOLIDATION: Pts receive methotrexate (MTX) IV over 4 hrs on day 1 and oral leucovorin calcium (CF) during wks 7, 10, 13, 16, and 19. Pts also receive MTX IT on wks 7, 10, 13, 16, 19, and 22; oral mercaptopurine (6-MP) daily on wks 5-24; oral dexamethasone (DM) 2x on days 1-7 of wks 8 and 17; and vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 17, and 18. CONTINUATION: Pts receive oral 6-MP daily on wks 25-130; oral DM 2x on days 1-7 and vincristine sulfate (VCR) IV on days 1 and 8 during wks 25, 41, 57, 73, 89, and 105; oral MTX weekly on wks 25-130 (except during wks of IT MTX); and MTX IT on wks 25, 37, 49, 61, 73, 85, 97, and 109.
Receives: Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate
Arm III (combination chemotherapy)ExperimentalCONSOLIDATION: Pts receive methotrexate (MTX) IV and leucovorin calcium (CF) as in arm I on wks 7, 10, 13, 24, 27, and 30. Pts also receive oral mercaptopurine (6-MP) daily on wks 5-13 and then on wk 24 and continuing until the end of consolidation; MTX IT on wks 7, 10, 13, 16, 20, 21, and 30; oral dexamethasone (DM) twice daily on days 1-7 of wks 8, 16-18, and 28; vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 16-18, 28, and 29; pegaspargase intramuscularly on wk 16; daunorubicin hydrochloride IV on day 1 of wks 16-18; cyclophosphamide IV on day 1 of wk 20; cytarabine IV or subcutaneously on days 2-5 of wks 20 and 21; and oral thioguanine daily on days 1-14 of wks 20 and 21. CONTINUATION: Pts receive oral 6-MP daily on wks 33-130; oral dexamethasone (DM) twice a day on days 1-7 and VCR IV on days 1 and 8 during wks 41, 57, 73, 89, and 105; oral MTX weekly on wks 33-130 (except during wks of IT MTX); and MTX IT on wks 37, 49, 61, 73, 85, 97, and 109.
Receives: Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate
.Arm IV (combination chemotherapy)ExperimentalCONSOLIDATION: Pts receive methotrexate (MTX) and leucovorin calcium (CF) on wks 7, 10, 13, 24, 27, and 30. Pts receive mercaptopurine(6-MP) daily weeks 5-13 then beginning wk 24 and continuing until end of consolidation; MTX on wks 7, 10, 13, 16, 20, 21, and 30; dexamethasone (DM) 2x daily on days 1-7 of wks 8, 16-18, and 28; vincristine sulfate (VCR) day 1 of wks 8, 9, 16-18, 28, and 29; pegaspargase on wk 16; daunorubicin hydrochloride on day 1 of wks 16-18; cyclophosphamide on day 1 of wk 20; cytarabine on days 2-5 of wks 20 and 21; thioguanine daily on days 1-14 of wks 20 and 21. CONTINUATION: Pts receive mercaptopurine(6-MP) daily on weeks 33-130; oral dexamethasone (DM) twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41, 57, 73, 89, and 105; oral MTX weekly on weeks 33-130 (except during weeks of IV MTX); and IV MTX on weeks 37, 49, 61, 73, 85, 97, and 109.
Receives: Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate

What is being measured

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

  1. Event-free survival

    The test statistic will compare Kaplan-Meier curves with sample size derived from a modification of the Makuch-Simon method for historical controls

    Measured: 4 years

  2. Occurrence of anticipated failures

    An O'Brien-Fleming analysis will be conducted, with significance declared if the observed logrank Z-statistic exceeds the z/sqrt(IF), where IF=fraction of anticipated failures that have occurred and z=critical value of the final analysis.

    Measured: Up to 7 years

  3. Grade 3 or greater CNS toxicity rates assessed using NCI CTC version 2.0

    Measured: Up to 7 years

Secondary outcomes (2)

  1. Measures of laboratory factors (other than MRD)

    Cox multiple regression will be utilized.

    Measured: Up to 7 years

  2. Homocysteine levels

    Will be correlated to acute neurotoxicity by Cox regression.

    Measured: Up to 7 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2000
  3. Primary completionJul 2007

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
838 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005585
Sponsor's protocol ID
9904
Other IDs
COG-P9904, POG-9904, CDR0000067657, NCI-2012-02321
Status last verified
Jun 2013
First submitted
2 May 2000
Last updated
6 Apr 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Rabin KR, Gramatges MM, Borowitz MJ, Palla SL, Shi X, Margolin JF, Zweidler-McKay PA. Absolute lymphocyte counts refine minimal residual disease-based risk stratification in childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Sep;59(3):468-74. doi: 10.1002/pbc.23395. Epub 2011 Nov 18.

    PubMed 22102553

  • Xu H, Cheng C, Devidas M, Pei D, Fan Y, Yang W, Neale G, Scheet P, Burchard EG, Torgerson DG, Eng C, Dean M, Antillon F, Winick NJ, Martin PL, Willman CL, Camitta BM, Reaman GH, Carroll WL, Loh M, Evans WE, Pui CH, Hunger SP, Relling MV, Yang JJ. ARID5B genetic polymorphisms contribute to racial disparities in the incidence and treatment outcome of childhood acute lymphoblastic leukemia. J Clin Oncol. 2012 Mar 1;30(7):751-7. doi: 10.1200/JCO.2011.38.0345. Epub 2012 Jan 30.

    PubMed 22291082

  • Borowitz MJ, Devidas M, Hunger SP, et al.: Prognostic signficance of end consolidation minimal residual disease (MRD) in childhood acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group (COG). [Abstract] J Clin Oncol 26 (Suppl 15): A-10000, 2008.

  • Borowitz MJ, Devidas M, Hunger SP, Bowman WP, Carroll AJ, Carroll WL, Linda S, Martin PL, Pullen DJ, Viswanatha D, Willman CL, Winick N, Camitta BM; Children's Oncology Group. Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood. 2008 Jun 15;111(12):5477-85. doi: 10.1182/blood-2008-01-132837. Epub 2008 Apr 3.

    PubMed 18388178

  • Davies SM, Borowitz MJ, Rosner GL, Ritz K, Devidas M, Winick N, Martin PL, Bowman P, Elliott J, Willman C, Das S, Cook EH, Relling MV. Pharmacogenetics of minimal residual disease response in children with B-precursor acute lymphoblastic leukemia: a report from the Children's Oncology Group. Blood. 2008 Mar 15;111(6):2984-90. doi: 10.1182/blood-2007-09-114082. Epub 2008 Jan 8.

    PubMed 18182569

  • Hinds PS, Hockenberry MJ, Gattuso JS, Srivastava DK, Tong X, Jones H, West N, McCarthy KS, Sadeh A, Ash M, Fernandez C, Pui CH. Dexamethasone alters sleep and fatigue in pediatric patients with acute lymphoblastic leukemia. Cancer. 2007 Nov 15;110(10):2321-30. doi: 10.1002/cncr.23039.

    PubMed 17926333

  • Winick N, Martin PL, Devidas M, et al.: Delayed intensification (DI) enhances event-free survival (EFS) of children with B-precursor acute lymphoblastic leukemia (ALL) who received intensification therapy with six courses of intravenous methotrexate (MTX): POG 9904/9905: a Children's Oncology Group study (COG). [Abstract] Blood 110 (11): A-583, 2007.

  • Ramsey LB, Panetta JC, Smith C, Yang W, Fan Y, Winick NJ, Martin PL, Cheng C, Devidas M, Pui CH, Evans WE, Hunger SP, Loh M, Relling MV. Genome-wide study of methotrexate clearance replicates SLCO1B1. Blood. 2013 Feb 7;121(6):898-904. doi: 10.1182/blood-2012-08-452839. Epub 2012 Dec 11.

    PubMed 23233662

  • Yang JJ, Cheng C, Devidas M, Cao X, Campana D, Yang W, Fan Y, Neale G, Cox N, Scheet P, Borowitz MJ, Winick NJ, Martin PL, Bowman WP, Camitta B, Reaman GH, Carroll WL, Willman CL, Hunger SP, Evans WE, Pui CH, Loh M, Relling MV. Genome-wide association study identifies germline polymorphisms associated with relapse of childhood acute lymphoblastic leukemia. Blood. 2012 Nov 15;120(20):4197-204. doi: 10.1182/blood-2012-07-440107. Epub 2012 Sep 24.

    PubMed 23007406

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, cytarabine and daunorubicin hydrochloride in people with Leukemia, run by Children's Oncology Group at 123 sites in 6 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Canada, Australia, Switzerland, Netherlands and 1 more country. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 4 years). The study lists 3 primary outcomes in all. 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 NCT00005585, which also lists 9 linked publications.

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 6 Apr 2023.

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