Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where random
| Condition(s) | Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Myeloproliferative Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment. |
| Who can participate | Inclusion Criteria: * Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor. * Patients must have high-risk myeloid malignancy as an indication for transplantation defined as: * acute myeloid leukemia not in hematological remission prior to transplantation, * ≥ 3 remission of acute myeloid leukemia, * any myeloid malignancy with bi-allelic tp53 mutation, * any myeloid malignancy with complex karyotype, * therapy-related myeloid malignancy not in MRD-negative response * myelodysplastic syndrome with very high IPSS-R risk * any myeloid malignancy with monosomal or t(3;3) karyotype, * any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression * MDS/NPM unclassified not |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | St. Petersburg State Pavlov Medical University |
| Locations | Saint Petersburg, Russia |
| Start date | 2024-05-22 |
| NCT ID | NCT06532084 |
| Official listing | https://clinicaltrials.gov/study/NCT06532084 |