drugset / Trial / NCT01116232
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
Phase 2
Terminated
4 enrolled
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelSupportive care
Summary
This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.
Timeline
- Start
- 2010-08
- Primary completion
- 2013-05
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 14 mg/kg | Intravenous |
| Subject | Sirolimus | Small molecule | 4 mg | Oral |
| Subject | Tacrolimus | Small molecule | 0.03 mg/kg | Intravenous |