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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 07-006053
    NCT ID: NCT00381680
    Sponsor Protocol Number: AALL0433

About this study

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 treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. 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) and giving the drugs in different ways and different doses may kill more cancer cells.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vilmarie Rodriguez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20151137

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