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Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

2014-08-27 03:54:10 | BioPortfolio

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor 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 transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation with or without fludarabine followed by donor stem cell transplant for hematologic cancer.

Description

OBJECTIVES:

Primary

- Determine the incidence of grades III and IV graft-versus-host disease (GVHD) in patients with hematologic malignancies treated with immunosuppression comprising tacrolimus and mycophenolate mofetil after nonmyeloablative conditioning comprising total body irradiation with or without fludarabine and allogeneic stem cell transplantation.

- Determine the incidence of chronic extensive GVHD in patients treated with these regimens.

Secondary

- Determine the incidence of graft rejection in patients treated with these regimens.

- Determine the 1-year overall survival of patients treated with these regimens.

- Determine the incidence of grades II-IV acute GVHD in patients treated with these regimens.

- Determine the rate of disease progression in patients treated with these regimens.

- Determine the rate of relapse-related mortality in patients treated with these regimens.

- Determine the rate and duration of steroid use for the treatment of chronic GVHD in patients treated with these regimens.

OUTLINE: This is a multicenter study.

- Conditioning: Patients who have not undergone a prior autologous hematopoietic stem cell transplantation within the past 6 months receive fludarabine IV on days -4 to -2. All patients undergo total body irradiation on day 0.

- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo allogeneic PBSCT on day 0.

- Immunosuppression: Patients receive mycophenolate mofetil IV or orally twice daily on days 0-27. Patients also receive tacrolimus IV or orally twice daily on days -3 to 56 followed by a taper to day 180.

Patients are followed at 6, 12, and 18 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Chronic Myeloproliferative Disorders

Intervention

graft-versus-tumor induction therapy, fludarabine phosphate, mycophenolate mofetil, tacrolimus, peripheral blood stem cell transplantation, radiation therapy

Location

Huntsman Cancer Institute at University of Utah
Salt Lake City
Utah
United States
84112

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:10-0400

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Medical and Biotech [MESH] Definitions

The induction of prolonged survival and growth of allografts of either tumors or normal tissues which would ordinarily be rejected. It may be induced passively by introducing graft-specific antibodies from previously immunized donors, which bind to the graft's surface antigens, masking them from recognition by T-cells; or actively by prior immunization of the recipient with graft antigens which evoke specific antibodies and form antigen-antibody complexes which bind to the antigen receptor sites of the T-cells and block their cytotoxic activity.

Immunological rejection of tumor tissue/cells following bone marrow transplantation.

Immunized T-lymphocytes which can directly destroy appropriate target cells. These cytotoxic lymphocytes may be generated in vitro in mixed lymphocyte cultures (MLC), in vivo during a graft-versus-host (GVH) reaction, or after immunization with an allograft, tumor cell or virally transformed or chemically modified target cell. The lytic phenomenon is sometimes referred to as cell-mediated lympholysis (CML). These CD8-positive cells are distinct from NATURAL KILLER CELLS and NATURAL KILLER T-CELLS. There are two effector phenotypes: TC1 and TC2.

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

Hypoxic conditions in tumor cells due to the tumor outgrowing its blood supply. It is associated with increased METASTASIS and resistance to RADIOTHERAPY and DRUG THERAPY.

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