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Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005585
  Purpose

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.


Condition Intervention Phase
Leukemia
 Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
 Phase III

MedlinePlus related topics:   Cancer    Leukemia, Childhood   

Drug Information available for:   Cyclophosphamide    Cytarabine    Cytarabine hydrochloride    Mercaptopurine    6-Mercaptopurine    Daunorubicin hydrochloride    Daunorubicin    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Vincristine sulfate    Vincristine    Calcium gluconate    Thioguanine    Pegaspargase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival at multiple time points [ Designated as safety issue: No ]

Study Start Date:   April 2000
Primary Completion Date:   September 2005 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005585

Show 123 study locations  Show 123 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul L. Martin, MD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications:
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. 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 Apr 3; [Epub ahead of print]
 
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 Acute Lymphoblastic Leukemia (ALL): a report from the Children's Oncology Group. Blood. 2008 Jan 8; [Epub ahead of print]
 
Hinds PS, Hockenberry MJ, Gattuso JS, Kumar Srivastava D, 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 Oct 9; [Epub ahead of print]
 
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.
 

Study ID Numbers:   CDR0000067657, COG-P9904, POG-9904
First Received:   May 2, 2000
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00005585
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission  
B-cell childhood acute lymphoblastic leukemia  

Study placed in the following topic categories:
Dexamethasone
Daunorubicin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Thioguanine
Vincristine
Leucovorin
Cyclophosphamide
6-Mercaptopurine
Folic Acid
Pegaspargase
Leukemia
Lymphatic Diseases
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on December 03, 2008

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