ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Children's Oncology Group
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
Drug: asparaginase
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: filgrastim
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: radiation therapy
Procedure: umbilical cord blood transplantation
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   Ifosfamide    Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Mercaptopurine    6-Mercaptopurine    L-Asparaginase    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    Cyclosporin    Cyclosporine    Imatinib    Imatinib mesylate    Etoposide phosphate    Calcium gluconate    Pegaspargase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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)

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
Estimated Primary Completion Date:   October 2007 (Final data collection date for primary outcome measure)

Show detailed description  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  Show 154 Study Locations

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

Investigators
Study Chair:     Kirk R. Schultz, MD     Children's & Women's Hospital of British Columbia    
  More Information


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

Publications of Results:
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.
 

Study ID Numbers:   CDR0000068859, COG-AALL0031
First Received:   August 10, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00022737
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Dexamethasone
Daunorubicin
Leukemia, Lymphoid
Cyclosporine
Clotrimazole
Miconazole
Leucovorin
Cyclophosphamide
6-Mercaptopurine
Cyclosporins
Etoposide phosphate
Leukemia
Pegaspargase
Methotrexate
Lymphoma
Etoposide
Dexamethasone acetate
Cytarabine
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Tioconazole
Vincristine
Recurrence
Folic Acid
Imatinib
Lymphatic Diseases
Ifosfamide
Lymphoproliferative Disorders
Isophosphamide mustard

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
Protein Kinase Inhibitors
Hormones
Vitamins
Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Micronutrients
Alkylating Agents
Dermatologic 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

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers