drugset / Trial / NCT05807932
Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML
Phase 1/2
Recruiting
38 enrolled
Heinrich-Heine University, Duesseldorf
Koordinierungszentrum für Klinische Studien - Duesseldorf · collab
NaSingle-groupOpen-labelTreatment
Summary
This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)
Timeline
- Start
- 2023-06-26
- Primary completion
- 2026-01-31
- Completion
- 2028-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | 100 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |
| Background | amsacrine | Small molecule | — | — |