Clinical Trial: Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic

Brief Summary:

RATIONALE: Giving 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) or interferon alfa 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation therapy works in treating patients who are undergoing donor stem cell transplant for chronic phase or accelerated phase chronic myelogenous leukemia.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the disease-free survival rate in patients with chronic or accelerated phase chronic myelogenous leukemia that failed or inadequately responded to prior imatinib mesylate treated with nonmyeloablative conditioning comprising fludarabine and low-dose total-body irradiation followed by allogeneic peripheral blood stem cell transplantation.

Secondary

  • Determine the complete cytogenetic and molecular response rates in patients treated with this regimen.
  • Determine overall survival of patients treated with this regimen.
  • Determine non-relapse mortality in patients treated with this regimen.
  • Determine the incidence of serious infection, graft-versus-host disease, and myelosuppression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Conditioning treatment: Patients receive fludarabine IV on days -4 to -2. Patients undergo low-dose total-body irradiation (TBI) on day 0.
  • Allogeneic peripheral blood stem cell transplantation: After TBI, patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
  • Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). Patients also receive oral mycophenolate mofetil twice daily on days 0-27.
  • Post-transplant
    Sponsor: Fred Hutchinson Cancer Research Center

    Current Primary Outcome: Progression-free survival

    Original Primary Outcome:

    Current Secondary Outcome:

    • Rate of complete molecular response
    • Late nonrelapse mortality
    • Incidence and severity of graft-vs-host disease (GVHD)
    • Incidence of serious infections
    • Myelosuppression
    • Overall survival and disease-free survival


    Original Secondary Outcome:

    Information By: Fred Hutchinson Cancer Research Center

    Dates:
    Date Received: May 3, 2005
    Date Started: February 2005
    Date Completion:
    Last Updated: November 15, 2011
    Last Verified: November 2011