Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
Summary
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 .
Timeline
- Start
- 2007-05
- Primary completion
- 2012-02
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |
| Subject | Sirolimus | Small molecule | 1 mg/m2 | Oral |
| Subject | Sirolimus | Small molecule | 4 mg | Oral |
| Subject | Tacrolimus | Small molecule | 0.02 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Background | Etoposide | Small molecule | 60 mg/kg | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |