Lymphoma Clinical Trial
Official title:
A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
RATIONALE: Giving chemotherapy and total-body irradiation 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 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, sirolimus, antithymocyte globulin, and
methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte
globulin work in preventing graft-versus-host disease in patients undergoing a donor stem
cell transplant for hematological cancer .
OBJECTIVES:
Primary
- To determine the incidence and severity of acute- and chronic-graft-versus-host disease
(GVHD) after HLA-matched or -mismatched unrelated donor hematopoietic peripheral blood
transplantation in patients with hematologic malignancies scheduled to receive
immunosuppressive combination of sirolimus, tacrolimus, and anti-thymocyte globulin as
GVHD prophylaxis.
- To determine the safety of this combination in the first six months post-transplant.
Secondary
- To determine the time-to-engraftment, non-relapse mortality rate, overall and
disease-free survival, incidence of disease relapse, and incidence of opportunistic
infections with this GVHD prophylaxis.
OUTLINE: Patients are stratified according to conditioning regimen (fludarabine phosphate
and melphalan vs fractionated total-body irradiation [FTBI] and etoposide vs FTBI and
cyclophosphamide) and degree of donor/recipient HLA mismatch (high-risk vs low-risk).
- Conditioning regimen: Patients receive 1 of 3 standard conditioning regimens beginning
on day -9 or -8 and continuing to day -1 or 0.
- Peripheral blood stem cell transplantation: Patients receive HLA-matched or mismatched
unrelated donor peripheral blood stem cells on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV continuously
beginning on day -3 and then orally when tolerated, oral sirolimus on days -3 and -2,
anti-thymocyte globulin IV over 4-8 hours on days -3 to 0, and methotrexate* IV on days
1, 3, and 6. Tacrolimus and sirolimus continue for 3-6 months (with taper).
NOTE: *Only patients with high-risk HLA mismatch receive treatment with methotrexate.
After completion of study therapy, patients are followed periodically for up to 2 years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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