Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
Recruitment status was Not yet recruiting
RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with mantle cell lymphoma.
Biological: donor lymphocytes
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma|
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- 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 patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720447
|Principal Investigator:||Simon Rule, MD||Derriford Hospital|