NCT05807932RecruitingPhase 1/2
Trial evaluating the safety and efficacy of Venetoclax in addition to a standard conditioning regime in patients with certain forms of leukemia undergoing allogeneic blood stem cell transplantation
Phase-I/II trial to assess the safety and efficacy of 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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 May 2026
Brief summary (registry, in English)
To find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and evaluate , whether the addition of Venetoclax to sequential conditioning with Fludarabine + Amsacrine + Ara-C (FLAMSA) + Treosulfan for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax) is safe
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 9 Jul 2024
- Start date
- 26 May 2023
- Lead sponsor
- Heinrich-Heine-Universitaet Duesseldorf
- NCT number
- NCT05807932
- EU CT number
- 2024-514688-24-00
- EudraCT number
- 2022-002435-66
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 38
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous cytotoxic therapy exceeding oral Hydroxyurea or >2 courses of treatment with Azacytidine, Decitabine or low dose Ara-C alone or in combination with Venetoclax
Who the study is looking for
- MDS, CMML or sAML according to WHO classification (revised version 2016) with a marrow blast count >5% and/or high-risk genetic features (eg. bad risk karyotype according to the IPSS-R / ELN classification or presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT), falling into the "high" or "very high" risk category of the IPSS-R or IPSS M) any time between diagnosis and inclusion.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.