Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia
- Determine the rates of durable full donor hematologic engraftment in patients with
high-risk hematologic malignancies or severe aplastic anemia treated with
non-myeloablative conditioning using fludarabine, cyclophosphamide, and anti-thymocyte
globulin followed by allogeneic peripheral blood stem cell transplantation.
- Determine the acute and delayed toxic effects of this non-myeloablative conditioning
regimen in this patient population.
- Determine the event-free and overall survival of patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.
- Determine the rate and quality of immune reconstitution in patients treated with this
- Determine the rate of disease relapse and incidence of post-transplantation
lymphoproliferative disease in these patients.
OUTLINE: Patients are stratified according to disease category (malignant vs non-malignant)
and graft source (unrelated vs HLA-matched sibling).
Beginning at least 4 weeks after conventional-dose chemotherapy, patients receive
non-myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -4,
cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin IV over at
least 4 hours on days -2 and -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic
peripheral blood stem cell transplantation on day 0.
Patients are followed weekly for 3 months, every 2 weeks for 3 months, monthly for 6 months,
and then every 2 months thereafter.
PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for this study within 4 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of Donor Engraftment
Peripheral blood from the donor and patient is obtained for chimerism studies. The primary analysis will consist of estimating the graft failure proportions for each of the separate patient groups and calculating confidence intervals for these proportions. This analysis will be done conditional on patients surviving at least 28 days.
at 28 days
Tamila Kindwall-Keller, DO
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|