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Status:

COMPLETED

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

B-cell Childhood Acute Lymphoblastic Leukemia

L1 Childhood Acute Lymphoblastic Leukemia

Eligibility:

All Genders

1-29 years

Phase:

PHASE3

Brief Summary

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in tr...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia....

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • Bone marrow with \> 25% L1 or L2 lymphoblasts (M3 marrow)
  • Patients with \> 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
  • Intermediate-risk relapsed disease, meeting 1 of the following criteria:
  • Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
  • Combined bone marrow and extramedullary (CNS\* and/or testicular\*\*) relapse ≥ 36 months after initial diagnosis
  • Isolated extramedullary (CNS\* and/or testicular\*\*) relapse \< 18 months after initial diagnosis
  • The following subtypes are not allowed:
  • T-lineage ALL
  • Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
  • Philadelphia-chromosome positive disease
  • No Down syndrome (trisomy 21)
  • Shortening fraction \>= 27% by echocardiogram OR ejection fraction \>= 50% by radionuclide angiogram
  • Bilirubin \< 3.0 mg/dL
  • Not pregnant
  • Fertile patients must use effective contraception
  • No history of peripheral neuropathy \>= grade 3 within the past month
  • No toxicity (i.e. peripheral neuropathy) \>= grade 3 attributable to vincristine within the past month
  • At least 5 days since prior intrathecal chemotherapy
  • No prior hematopoietic stem cell or marrow transplantation
  • No prior cranial radiotherapy \> 1200 cGy (for patients with CNS relapse)
  • No concurrent stem cell transplant
  • No concurrent alternative therapy
  • No concurrent itraconazole in patients receiving vincristine
  • No concurrent intensity-modulated radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    275 Patients enrolled

    Trial Details

    Trial ID

    NCT00381680

    Start Date

    March 1 2007

    Last Update

    March 26 2024

    Active Locations (173)

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    Page 1 of 44 (173 locations)

    1

    Children's Hospital of Alabama

    Birmingham, Alabama, United States, 35233

    2

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    3

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    4

    University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724