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Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia
This study has been completed.

First Received on August 10, 2001.   Last Updated on October 15, 2011   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022737
  Purpose

RATIONALE: Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: ifosfamide
Drug: imatinib mesylate
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: vincristine sulfate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Children's Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (STI571 NSC#716051/IND#55666)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Feasibility, in terms of toxicity and patient accrual [ Designated as safety issue: Yes ]
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Feasibility of administering hematopoietic stem cell transplantation after the second consolidation block of chemotherapy [ Designated as safety issue: No ]
  • Prognostic effect of minimal residual disease assays [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: October 2002
Primary Completion Date: July 2009 (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
  • Received prior front-line therapy on a Pediatric Oncology Group (POG), Children's Cancer Group (CCG), or Central Oncology Group (COG) study OR
  • Received induction therapy comprising vincristine, asparaginase, prednisone/dexamethasone, and daunorubicin as in CCG, POG, or COG protocols
  • M1 or M2 bone marrow status after front-line induction therapy and presenting with at least 1 of the following:

    • Philadelphia chromosome positive (Ph+) with t(9;22)(q34;q11) by cytogenetics or fluorescence in situ hybridization
    • bcr-abl fusion transcript by reverse transcription polymerase chain reaction
    • Hypodiploid with less than 44 chromosomes and/or DNA index less than 0.81
    • MLL translocation (11q23) by cytogenetics and a slow early response (SER) to induction therapy, defined as at least 5% blasts at day 15 of induction and/or at least .1% minimal residual disease (MRD) after induction therapy OR
  • Failed to achieve remission after front-line induction therapy

    • M3 bone marrow status (greater than 25% blasts) after induction therapy OR
    • M2 bone marrow status (5-25% blasts) or at least 1% MRD after induction therapy and M2 or M3 or at least 1% MRD after consolidation therapy (CCG studies) or extended induction therapy (POG or COG studies)

PATIENT CHARACTERISTICS:

Age:

  • 1 to 21

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • No concurrent prophylactic cranial radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022737

  Show 154 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Kirk R. Schultz, MD Children's and Women's Hospital of British Columbia
  More Information

Additional Information:
Publications:
Carroll AJ, Heerema NA, Devidas M, et al.: Secondary chromosomal abnormalities appear to be less prognostic for children with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) treated with intensified imatinib and chemotherapy: results of the Children's Oncology Group (COG) study AALL0031. [Abstract] Blood 114 (22): A-2606, 2009.
Chang BH, Willis SG, Stork LC, et al.: Mutational analysis of BCR-Abl from subjects with relapsed Ph+ALL treated on the COG protocol AALL0031: A report from the Children's Oncology Group. [Abstract] Blood 114 (22): A-2634, 2009.
Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved Early Event-Free Survival With Imatinib in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Children's Oncology Group Study. J Clin Oncol. 2009 Oct 5; [Epub ahead of print]
Schultz KR, Bowman WP, Slayton W, et al.: Philadelphia chromosome negative (Ph-) very high risk (VHR) acute lymphoblastic leukemia (ALL) in children and adolescents: the impact of intensified chemotherapy on early event free survival (EFS) in Children's Oncology Group (COG) study AALL0031. [Abstract] Blood 112 (11): A-911, 2008.
Schultz KR, Aledo A, Bowman WP, et al.: Minimal toxicity of imatinib mesylate in combination with intensive chemotherapy for Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) in children: a report of the Childrens Oncology Group (COG) AALL0031 protocol for very high risk ALL. [Abstract] Blood 108 (11): A-283, 2006.

ClinicalTrials.gov Identifier: NCT00022737     History of Changes
Other Study ID Numbers: CDR0000068859, COG-AALL0031
Study First Received: August 10, 2001
Last Updated: October 15, 2011
Health Authority: United States: Federal Government

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

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
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Cyclosporins
Cyclosporine
Isophosphamide mustard
Pegaspargase
Imatinib
Asparaginase
Daunorubicin
Dexamethasone
Etoposide
Ifosfamide
Vincristine
BB 1101
Lenograstim
Dexamethasone acetate
Dexamethasone 21-phosphate
Leucovorin
Levoleucovorin

ClinicalTrials.gov processed this record on February 12, 2012