Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma
- Determine progression-free survival in patients with mantle cell lymphoma undergoing
low-intensity allogeneic stem cell transplantation.
- Determine overall survival of these patients.
- Determine the toxicity by way of adverse event profile of this regimen in these
OUTLINE: This is a multicenter study.
- Reduced intensity conditioning: Patients receive carmustine IV over 2 hours on day -6,
etoposide IV over 1 hour and cytarabine IV over 15 minutes on days -5 to -2,
alemtuzumab IV over 2 hours on days -5 to -1, and melphalan IV on day -1.
- Donor stem cell transplant: Patients undergo stem cell transplantation on day 0 with
filgrastim (G-CSF)-mobilized peripheral blood stem cells or bone marrow stem cells.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or
orally on day -1 to 30 and taper to day 100.
- Donor lymphocyte infusion (DLI) therapy: Patients with evidence of disease progression,
mixed chimerism, or low level residual disease undergo DLI every 3 months for up to 15
months in the absence of GVHD.
After completion of study, patients are followed every 3 months for 2 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Simon Rule, MD