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Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
This study has been completed.
First Received: May 2, 2000   Last Updated: August 23, 2008   History of Changes
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: Dexamethasone Cyclophosphamide 6-Mercaptopurine Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Citrovorum factor Dexamethasone acetate Doxiproct plus Pegaspargase Cytarabine Thioguanine Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Folinic acid calcium salt pentahydrate Mercaptopurine
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

  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
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Paul L. Martin, MD Duke University
  More Information

Additional 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
Study First Received: May 2, 2000
Last Updated: August 23, 2008
ClinicalTrials.gov Identifier: NCT00005585     History of Changes
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:
Anti-Inflammatory Agents
Acute Lymphoblastic Leukemia, Childhood
Dexamethasone
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Leucovorin
Cyclophosphamide
6-Mercaptopurine
Hormones
Anti-Bacterial Agents
 Leukemia
Pegaspargase
Vitamins
Methotrexate
Micronutrients
Alkylating Agents
Lymphoma
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia
Vitamin B Complex
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Thioguanine

Additional relevant MeSH terms:
Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Pegaspargase
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
 Nucleic Acid Synthesis Inhibitors
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Thioguanine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors

ClinicalTrials.gov processed this record on May 07, 2009



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