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Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS
Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS
Details
| Lead sponsor | University Hospital Tuebingen |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 27 |
| Start date | 2026-01 |
| Completion | 2027-12 |
Conditions
- AML (Acute Myeloid Leukemia)
- MDS/AML
- MDS (Myelodysplastic Syndrome)
Interventions
- RIC regimen
Primary outcomes
- Overall survival (OS) — at day 28 after alloHCT
Primary objective of this trial is to evaluate the feasibility and safety of the augmentation of a treosulfanbased RIC regimen for alloHCT in AML, MDS/AML and HR-MDS patients with the Bcl-2-inhibitor Venetoclax. As outlined above, the aim is to increase antileukemic acitiviy without increasing morbidity and mortality in a vulnerable patient collective. This is operationalized by the following primary endpoint: 1\) Overall survival (OS) at day 28 after alloHCT Most adverse events (AEs) due to the IMPs are expected to occur before day 0. Protacted or lateonset toxicities with potentially lethal consequences cannot be ruled out. Therefore, we regard it most suitable to evaluate overall survival at day 28 after alloHCT.
Countries
Germany