Title A Phase II Trial of Reduced Intensity Allogenenic Stem Cell Transplantation With Fludarabine, Melphalan and low Dose Total Body Irradiation
Contact LY
Principal Investigator Hong Liu MD
Study Number 177110
Phase2
Summary
Reduced intensity conditioning during allogeneic hematopoietic stem cell transplant (HSCT) reduces transplant related mortality (TRM) by relying more on the graft-versus-malignancy effect rather than the conditioning regimen to eradicate disease. Reduced intensity conditioning regimens can provide a curative option for patients with hematologic malignancies who might otherwise not be candidates for myeloablative (intensive) transplantation because of age or poor performance status. Since the ability to perform transplant safely is the primary measure of efficacy for reduced intensity conditioning, TRM is the appropriate measure of efficacy of the conditioning regimen.
Eligibility
- Diagnosis of a histology documented hematologic malignancy or marrow disorder.
- Age >= 4 and <= 75 years for blood and bone marrow transplants
- Patients may have received prior autologous BMT or prior myeloablative allogeneic BMT (at least 90 days have elapsed)
- At least 2 weeks since prior chemotherapy, radiation treatment and/or surgery
- No serious uncontrolled psychiatric illness
- No concomitant active malignancy that would be expected to require chemotherapy within 3 years of transplant (other than non-melanoma skin cancer)
- Informed consent