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Imatinib Mesylate and Combination Chemotherapy in Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia


Title International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones. 
Therapeutic Area Leukemias (Pediatric)
Principal Investigator Michael Kelly, MD
Min Age 2 Years
Max Age 21 Years
Gender All
Contact Jordan Pothier
617-636-8885
More Information https://www.clinicaltrials.gov/ct2/show/NCT03007147

Overview

This randomized phase III trial studies how well imatihib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Study Details

Inclusion Criteria

  • Patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fiuorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
    • For patients who DO NOT enter AALL1631 via AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients), laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
    • Patients with known chronic myelogenous leukemia (CML) who develop lymphoid blast crisis are not eligible
  • Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy

Exclusion Criteria

  • Known history of chronic myelogenous leukemia (CML)
  • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation

Study Requirements

All subjects will receive Induction therapy for two weeks according to institutional standard of care procedures. They will then begin imatinib once daily after day 14. Patients will be on study for approximately 4 years. Bone marrow evaluations will be performed throughout to assess the subject's response to treatment.