drugset / Trial / NCT03963024
Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT
NaSingle-groupOpen-labelTreatment
Summary
TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT). The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.
Timeline
- Start
- 2014-02-12
- Primary completion
- 2019-01-31
- Completion
- 2019-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Antithymocyte globulin (ATG)-Fresenius | Unknown | 5 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Mycofenolate mofetile | Unknown | 10 mg/kg | — |
| Background | Rituximab | Monoclonal antibody | 200 mg/m2 | Intravenous |
| Background | Sirolimus | Small molecule | 4 mg | Oral |
| Background | Treosulfan | Small molecule | 14 g | Intravenous |