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Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
This study has been completed.

First Received on November 12, 2002.   Last Updated on December 17, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049569
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
 Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: imatinib mesylate
Drug: leucovorin calcium
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Intensive Induction Therapy For Children With Acute Lymphoblastic Leukemia (ALL) Who Experience A Bone Marrow Relapse

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia
Drug Information available for: Hydrocortisone acetate Cyclophosphamide Hydrocortisone Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Etoposide Citrovorum factor Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Etoposide phosphate Filgrastim Pegaspargase Lenograstim Granulocyte colony-stimulating factor Imatinib Imatinib mesylate Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Vincristine sulfate Cortisol succinate Cortisol 21-phosphate Folinic acid calcium salt pentahydrate L-Asparaginase
U.S. FDA Resources

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

Study Start Date: January 2003
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow)

    • Philadelphia chromosome-positive patients eligible with or without extramedullary disease
    • No prior isolated extramedullary relapse
  • No B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique)
  • No Down syndrome

PATIENT CHARACTERISTICS:

Age

  • 1 to 21 at time of relapse

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • Shortening fraction at least 28% by echocardiogram
  • Ejection fraction at least 50% by MUGA

Other

  • No active fungal infection
  • No prior invasive filamentous fungal infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 12 months since prior stem cell transplantation
  • No other concurrent immunomodulating agents

Chemotherapy

  • Prior cumulative anthracycline exposure no greater than 350 mg/m^2
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent cytotoxic therapy
  • No concurrent immunosuppressive therapy for graft-vs-host disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049569

  Show 232 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Elizabeth A. Raetz, MD Mount Sinai School of Medicine
  More Information

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

Publications:
Raetz EA, Borowitz MJ, Devidas M, Linda SB, Hunger SP, Winick NJ, Camitta BM, Gaynon PS, Carroll WL. Reinduction platform for children with first marrow relapse in acute lymphoblastic lymphoma. J Clin Oncol. 2008 Aug 20;26(24):3971-8.
Raetz EA, Borowitz MJ, Devidas M, et al.: Outcomes of children with first marrow relapse: results from Childrens Oncology Group (COG) study AALL01P2. [Abstract] Blood 108 (11): A-1871, 2006.
Borowitz MJ, Devidas M, Hunger SP, et al.: Minimal residual disease (MRD) in childhood acute lymphoblastic leukemia (ALL) in relapse. A Children's Oncology Group (COG) study. [Abstract] Blood 104 (11): A-324, 2004.
Bhojwani D, Kang H, Moskowitz N, et al.: Biological pathways associated with relapse in childhood acute lymphoblastic leukemia: a Children's Oncology Group study. [Abstract] Blood 108 (2): 711, 2006.

ClinicalTrials.gov Identifier: NCT00049569     History of Changes
Other Study ID Numbers: CDR0000258120, COG-AALL01P2
Study First Received: November 12, 2002
Last Updated: December 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
non-T, non-B childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Imatinib
Asparaginase
Cyclophosphamide
Cytarabine
Doxorubicin
 Etoposide
Methotrexate
Prednisone
Vincristine
Lenograstim
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012



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