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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2010
First Received: February 7, 2005   Last Updated: February 6, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103285
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
Official Title: Standard Risk B-precursor Acute Lymphoblastic Leukemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-free survival (EFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Designated as safety issue: No ]
  • Correlation of minimal residual disease (MRD) with EFS and overall survival at day 29 [ Designated as safety issue: No ]
  • Correlation of early marrow response status with MRD at day 29 [ Designated as safety issue: No ]
  • Identification of additional high-risk patients by day 29 MRD [ Designated as safety issue: No ]
  • Contribution of genetic factors and early treatment response to outcome [ Designated as safety issue: No ]

Estimated Enrollment: 3381
Study Start Date: January 2005
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1 (SR-low ALL), arm I: Active Comparator
Patients receive Part I therapy. Patients then receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 1 (SR-low ALL), arm II: Experimental
Patients receive Part I therapy. Patients then receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 2 (SR-average ALL), arm I: Active Comparator
Patients receive Part I therapy. Patients then receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 2 (SR-average ALL), arm II: Experimental
Patients receive Part I therapy. Patients then receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 2 (SR-average ALL), arm III: Active Comparator
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 2 (SR-average ALL), arm IV: Active Comparator
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Group 3 (SR-high ALL): Experimental
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Radiation: radiation therapy
Some patients undergo cranial radiotherapy

  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:

  • Newly diagnosed B-precursor acute lymphoblastic leukemia

    • Standard-risk (SR) disease meeting 1 of the following criteria:

      • SR-average by age and WBC

        • No unfavorable features
        • Rapid early responder (RER) by day 15
        • CNS 1 or 2
        • Minimal residual disease (MRD) negative on day 29
        • Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
      • SR-low by age and WBC

        • No unfavorable features
        • RER by day 15
        • MRD negative on day 29
        • CNS1
        • Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
      • SR-high

        • Unfavorable features meeting ≥ 1 of the following criteria:

          • MLL rearrangements and RER
          • Steroid pretreatment
          • CNS3
          • Slow early responder by morphology or MRD
  • Patients with Down syndrome are allowed
  • Concurrently enrolled on COG-AALL03B1

PATIENT CHARACTERISTICS:

Age

  • 1 to under 10

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Initial WBC < 50,000/mm^3

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy except intrathecal cytarabine

Endocrine therapy

  • Prior steroid therapy allowed at the discretion of the investigator
  • No contraindication to additional asparaginase therapy after induction for the standard risk-low study

Radiotherapy

  • No concurrent intensity-modulated radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103285

  Show 202 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Kelly Maloney, MD Children's Hospital Center for Cancer and Blood Disorders
Investigator: Leonard A. Mattano, MD Bronson Methodist Hospital
Investigator: Linda C. Stork, MD Doernbecher Children's Hospital at Oregon Health & Science University
  More Information

Additional Information:
Publications:
Buchanan N, Maloney K, Tsang S, et al.: Risk of depression, anxiety, and somatization one month after diagnosis in children with standard risk ALL on COG AALL0331. [Abstract] J Clin Oncol 26 (Suppl 15): A-10052, 2008.
Stork LC, Buchanan N, Maloney K, et al.: Impairments in social and adaptive functioning one month after diagnosis in children with standard risk ALL on COG AALL0331. [Abstract] J Clin Oncol 26 (Suppl 15): A-10034, 2008.
Maloney KW, Larsen E, Mattano LA, et al.: Increased infection-related mortality for children with Down syndrome (DS) in contemporary Childrens Oncology Group (COG) acute lymphoblastic leukemia (ALL) clinical trials. [Abstract] Blood 108 (11): A-1865, 2006.

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000409589, COG-AALL0331
Study First Received: February 7, 2005
Last Updated: February 6, 2010
ClinicalTrials.gov Identifier: NCT00103285     History of Changes
Health Authority: Unspecified

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

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
Doxorubicin
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors

ClinicalTrials.gov processed this record on February 08, 2010