Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
OBJECTIVES:
I. To determine if engraftment can be achieved safely in patients with high-risk hematologic
malignancies who undergo non-myeloablative bone marrow transplantation (BMT) from human
leukocyte antigen (HLA)-haploidentical donors.
OUTLINE:
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV)
over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients
undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day
3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and
then tacrolimus orally (PO), once tolerated, on days 4-180, with taper on day 86 in the
absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three
times daily on days 4-35.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 months and then annually
thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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