Clinical Trial: Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

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

Official Title: A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation

Brief Summary:

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.

Detailed Summary:

OBJECTIVES:

Primary

• To assess safety and toxicity of the addition of busulfan added to an established fludarabine and low-dose total-body irradiation (TBI) conditioning regimen for non-myeloablative allogeneic transplantation in patients with hematologic malignancies. (Phase I)
• To assess the non-relapse mortality 1-year after conditioning with busulfan and fludarabine/TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. (Phase II)

Secondary

• To assess overall survival 1-year survival. (Phase II)
• To assess the incidence of graft rejection. (Phase II)
• To assess the incidence of grade II-IV acute graft-vs-host disease (GVHD) and chronic extensive GVHD. (Phase II)
• To assess rates of disease progression and/or relapse-related mortality. (Phase II)
• To determine non-hematologic grade III-IV organ specific toxicity. (Phase II)

OUTLINE:

• Nonmyeloablative-conditioning regimen: Patients receive busulfan IV on day -5 and fludarabine IV over 30 minutes on days -4 to -2. Patients undergo total body irradiation on day 0.
• Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo donor PBSC infusion on day 0.
• Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine twice daily on days
  Sponsor: OHSU Knight Cancer Institute
  

  Current Primary Outcome:

  • Safety [ Time Frame: 5 years ]
    Evaluations at 6 months, 12 months, 18 months and subsequent yearly follow-up's for a total of 5 years.
  • Non-relapse mortality [ Time Frame: 5 years ]
    Chimerisms and post-engraftment are followed on days 28, 56, and 84 post transplant with an evaluation at 180 days (6 months), then 1 year, 18 months, 2, 3, 4, & 5 years after.
  
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: OHSU Knight Cancer Institute
  

  Dates:
  Date Received: October 25, 2005
  Date Started: June 2005
  Date Completion:
  Last Updated: February 23, 2017
  Last Verified: February 2017