Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma
RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide,
before a donor bone marrow transplant helps stop the growth of cancer cells. It may also
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. Sometimes the
transplanted cells from a donor can make an immune response against the body's normal cells.
Giving cyclosporine, methylprednisolone, and methotrexate after transplant may stop this
from happening.
PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide
followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic
syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.
OBJECTIVES:
I. To determine the toxicity and efficacy of the high-dose chemotherapy regimen which
employs busulfan, cyclophosphamide, and allogeneic bone marrow transplantation.
II. To ascertain feasibility (safety) and efficacy of the use of intensive chemotherapy
regimen (busulfan and cyclophosphamide) followed by allogeneic bone marrow transplantation
in patients with leukemia, myelodysplastic syndromes, multiple myeloma, and lymphoma.
OUTLINE:
HIGH-DOSE CHEMOTHERAPY: Patients receive oral busulfan every 6 hours on days -8 to -5 and
cyclophosphamide IV over 2 hours on days -4 and -3, or -4 to -2 .
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplant IV over 2-3 hours on day
0.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine IV over 6 hours on day
-1, over 10 hours twice daily on days 0-20, and then orally every 12 hours beginning on day
21 and continuing for 12 months with taper at 9 months. Patients also receive
methylprednisolone IV or orally beginning on day 8 and continuing for 7 months with taper at
4 months. Some patients may also receive methotrexate IV on days 1, 3 and 6 .
After completion of study treatment, patients are followed up periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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