Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia
NCT00110058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2011-11-17
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.
Conditions
Interventions
- BIOLOGICAL
-
recombinant interferon alfa
- BIOLOGICAL
-
therapeutic allogeneic lymphocytes
- DRUG
-
cyclosporine
- DRUG
-
fludarabine phosphate
- DRUG
-
imatinib mesylate
- DRUG
-
mycophenolate mofetil
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Brenda Sandmaier, MD · Fred Hutchinson Cancer Center
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Completion
- 2006-07-31
Countries
- United States
Study Locations
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