Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia
- Determine if allogeneic stem cell transplantation using unrelated matched or related
haploidentical donor bone marrow or unrelated matched cord blood results in timely,
complete, and durable engraftment in patients with previously treated lymphoma,
multiple myeloma, or chronic lymphocytic leukemia.
- Determine the incidence and grade of acute and chronic graft-versus-host disease in
patients treated with this regimen.
- Determine if the augmented graft-versus-tumor effect accompanying unrelated or
partially matched donor allogeneic transplant reduces the incidence of relapse in these
- Preparative regimen: Patients receive cyclophosphamide IV over 2 hours on days -7 and
-6 and undergo total-body irradiation (TBI) twice daily on days -4 to -1. Patients who
are unable to undergo TBI receive busulfan IV or orally 4 times daily on days -9 to -6
and cyclophosphamide IV over 2 hours on days -5 to -2.
- Stem cell transplantation: All patients undergo unrelated matched bone marrow or
umbilical cord blood transplantation or partially matched related allogeneic bone
marrow transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis
comprising methotrexate and cyclosporine. Patients may be enrolled in other protocols
directed towards GVHD prophylaxis.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Daniel J. Weisdorf, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|