A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies
- Determine the overall and event-free survival at 1 year in patients with B-cell
non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with a nonmyeloablative
conditioning regimen, rituximab, and allogeneic hematopoietic stem cell
- Determine the speed of neutrophil and platelet recovery in patients treated with this
- Determine the incidence and speed of donor-derived engraftment in these patients.
- Determine the incidence and severity of acute graft versus host disease (GVHD) at 100
days in patients treated with this regimen.
- Determine the incidence and severity of chronic GVHD at 1 year in patients treated with
- Correlate the incidence of serious infectious complications with immune recovery in
patients treated with this regimen.
- Determine the response in patients treated with this regimen.
- Determine the incidence of transplant-related mortality at 100 and 180 days in these
- Determine the incidence of malignant relapse or disease progression at 1 and 2 years in
- Determine the probabilities of overall and event-free survival at 2 years in patients
treated with this regimen.
OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched
unrelated or single HLA allele-disparate related or unrelated).
- Rituximab therapy: Patients receive rituximab IV on day -8 or -7 and on days 21, 28,
35, and 42.
- Nonmyeloablative conditioning: Patients receive fludarabine phosphate IV over 30
minutes on days -6 to -2, cyclophosphamide IV on day -6, and anti-thymocyte globulin
(ATG)* IV over 4-6 hours on days -3 and/or -2. Patients undergo total-body irradiation
on day -1.
NOTE: *Patients with HLA-matched sibling donors do not receive ATG.
- Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo filgrastim
(G-CSF)-mobilized allogeneic HSCT on day 0. Patients receive filgrastim (G-CSF) IV or
subcutaneously beginning on day 7 and continuing until blood counts recover.
- Graft versus host disease prophylaxis: Patients receive cyclosporine IV over 2-4 hours
or orally twice daily on days -3 to 100 followed by a taper and mycophenolate mofetil
IV or orally twice daily on days -3 to 45 followed by a taper, in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for 2 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall and event-free survival at 1 year
Hugo R. Castro-Malaspina, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|