Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
- To assess the efficacy and toxicity of reduced-intensity allogeneic peripheral blood
stem cell transplantation in patients with hematological malignancies treated with
conditioning therapy comprising fludarabine phosphate and busulfan.
- To evaluate progression-free survival and overall survival in patients treated with
- To determine donor chimerism.
- To access the risk of acute and chronic graft-versus-host-disease (GVHD) in patients
treated with this regimen.
- Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and
fludarabine phosphate IV over 30 minutes on days -6 to -2.
- Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic
PBSC on day 0.
- Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients
achieve100% donor T-cell chimerism on day 30 without disease recurrence, and
cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1
to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every
12 hours on days 1-40, in the absence of ≥ grade 2 GVHD.
Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a
12-day CSA and MMF taper followed by escalating doses of previously collected donor
leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in
the absence of ≥ grade 2 GVHD.
After completion of study treatment, patients are followed periodically.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Day 100 transplant-related mortality
Up to 2 years
Carol M. Richman, MD
University of California, Davis
United States: Food and Drug Administration
|University of California Davis Cancer Center||Sacramento, California 95817|