Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With H
Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD
| Condition(s) | Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia, Myelodysplastic Syndromes (MDS), Myeloprolipherative Neoplsm, Atypical Chronic Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD |
| Who can participate | Inclusion Criteria: * Patients with indication for allogeneic hematopoietic stem cell transplantation * Patients with \<10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. * Peripheral blood stem cells or bone marrow as a graft source * Diagnosis: Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardl |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | St. Petersburg State Pavlov Medical University |
| Locations | Saint Petersburg, Russia |
| Start date | 2025-05-10 |
| NCT ID | NCT07238712 |
| Official listing | https://clinicaltrials.gov/study/NCT07238712 |