Intensive treatment for intermediate-risk relapse of childhood B-precursor acute lymphoblastic leukemia (ALL); a randomized trial of vincristine strategies

eagle-i ID

Resource Type

Properties

1. Intervention

   Vincristine

2. Additional Topic(s)

   Drug dosage

3. Additional Topic(s)

   Stem cell transplantation

4. Resource Description

   Children with an initial late bone marrow or combined relapse, or an early isolated extramedullary relapse of acute lymphoblastic leukemia (ALL) have relatively poor overall outcome, with an event-free survival for early CNS and late marrow of 30-60%. EF for early testicular relapse is also < 60%. Combined, this group of patients has an intermediate prognosis compared to patients with early marrow relapse or late isolated extramedullary relapse. The major cause of failure in all of these subgroups (including isolated extramedullary relapse) is subsequent relapse in the marrow. The overall goal of this study is to establish the efficacy of an intensive chemotherapy regimen for patient with intermediate-risk relapse of childhood B-precursor ALL. Researchers want to know if they can improve the cure rate for intermediate-risk relapse ALL by intensive dosing of vincristine, to the standard chemotherapy treatments. Study participants will be randomized to receive one of two different treatment plans, either Arm A, which is the current standard therapy, or Arm B, which is considered the experimental arm. Arm A uses the current standard dose therapy Vincristine. Vincristine has been given safely to children with ALL before but it has not been compared to the higher dose. Another goal of this study is to compare the outcomes of patients treated with chemotherapy vs. matched sibling family donor hematopoietic stem cell transplantation (SCT) for those with eligible donors. We will also be studying the use of DNA arrays to characterize patterns of gene expression that predict treatment failure, and to compare gene expression profiles at the time of relapse with those at initial diagnosis to gain an understanding of the pathways that may be involved in disease resistance and to determine whether common polymorphisms in candidate genes are associated with the frequency of vincristine adverse effects (peripheral neuropathy, SIADH, or constipation) and with anti-leukemic response (level of end-induction MRD).

5. Contact

   Berenberg, Jeffrey

6. PI

   Wilkinson, Robert, M.D.

7. Study Population

   Patients between 1 and 29.99 years of age (inclusive) at the time of relapse. Patient with an intermediate-risk relapse of B-precursor ALL (Bone marrow relapse > 36 months from initial diagnosis or combined bone marrow and extramedullary (CNS and/or testicular) relapse >36 months from diagnosis, isolated extramedullary (CNSand/or testicular) relapse < 18 months from diagnosis.

8. Website(s)

   http://www.curesearch.org/ArticleView2.aspx?id=7290&l=8673

9. Funded by

   Children's Oncology Group

10. Phase

    Phase 3 clinical trial

11. Performed by

    Clinical Protocol & Data Management Shared Resource