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Bone Marrow Transplant

Fludarabine + Radiation Followed by SCT for Ph+ ALL Patients (FHCRC-1581)
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive PH+ Acute Leukemia - A Multi-Center Trial
Status Conditions Phase Study ID
Closed Leukemia Phase I/II FHCRC-1581
NCT00036738
Summary

RATIONALE: Giving imatinib mesylate, dasatinib, or nilotinib low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine and total-body irradiation followed by donor peripheral stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib.


Investigator
George Georges, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) or chronic myelogenous leukemia in blast crisis

    • Less than 15% blasts on morphologic bone marrow evaluation after receiving imatinib mesylate, dasatinib, or nilotinib

      • Patients with no detectable Ph+ ALL by morphologic or molecular assay (i.e., complete remission) after treatment with imatinib mesylate, dasatinib, or nilotinib are eligible
      • Patients who initially respond to imatinib mesylate, dasatinib, or nilotinib and then progress are ineligible for nonmyeloablative stem cell transplantation on this protocol
  • No CNS involvement with leukemia refractory to intrathecal chemotherapy
  • Availability of an HLA-matched related or unrelated peripheral blood stem cell donor

    • Related donors HLA genotypically identical for at least 1 haplotype and may be genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, and -DQB1 alleles

      • No identical twin OR
    • Unrelated donors meeting the following criteria:

      • Matched for HLA-A, -B, -C, -DRB1, and -DQB1 by high-resolution typing
      • Only a single allele disparity allowed for HLA-A, -B, or -C by high-resolution typing
    • No bone marrow donors
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.