Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil
This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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.
PRIMARY OBJECTIVES:
I. To estimate the incidence of grade III/IV graft-versus-host disease (GVHD) after
conditioning with 200 centigray (cGy) TBI alone or Fludarabine (fludarabine phosphate)/200
cGy TBI followed by tacrolimus (Tac)/mycophenolate mofetil (MMF) immunosuppression in
patients with hematologic malignancies.
II. To estimate the incidence of chronic extensive GVHD.
SECONDARY OBJECTIVES:
I. To estimate the incidences of graft rejection.
II. To estimate overall survival 1-year after conditioning.
III. To evaluate the incidences of grades II-IV acute GVHD.
IV. To evaluate the rates of disease progression and/or relapse-related mortality.
V. To estimate the rate and duration of steroid use for the treatment of chronic GVHD.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I (nonmyeloablative conditioning with fludarabine phosphate and TBI): Patients receive
fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0.
ARM II (nonmyeloablative conditioning with TBI): Patients undergo TBI on day 0.
All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and
receive tacrolimus orally (PO) every 12 hours on days -3 to 180, with taper on day 56, or
tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days
0-27 or mycophenolate mofetil IV if unable to tolerate PO.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 3 years.
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| Status | Clinical Trial | Phase | |
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