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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

StatusRecruiting
PhasePhase 1/2
Started2023-06-26
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 39 months later Jan 31, 2026 → Apr 30, 2029
See other at-risk trials from Heinrich-Heine University, Duesseldorf

Amendment history

2026-09-17
Primary completion pushed: 2026-01-31 → 2029-04-30
Completion pushed: 2028-01-30 → 2029-04-30
2024-04-30
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 6 sites
2023-11-16
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria-71 characters
[...] nitiation of any study-specific procedures MDS, CMML or sAML (marrow blast count <30%) according to WHO classification (revised version 2016) with a marrow blast count >5% and/or high-risk genetic features (e.g. bad risk karyotype accordi [...] "high" or "very high" risk category of the IPSS-R or IPSS-M), or a marrow blast count >20% any time between diagnosis and inclusion Untreated except for oral Hydroxyurea <60 days or a maximum of 2 courses of treatment with Azacytidine or [...] C, DR, DQ) donor either related or unrelated Age ≥18 HCT-CI <≤ 3 (except former treatment of a solid tumor) ECOG performan [...] xy [...]
Study sitesdetails revised at 1 of 6 sites
2023-09-15
Study Status, Contacts/Locations v3
Study sites3→6
2023-07-06
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 3 sites
2023-06-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05-01→confirmed 2023-06-26
Study sitesdetails revised at 3 of 3 sites
2023-03-29
Original filing
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)
Trial Details
NCT Number NCT05807932
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: Koordinierungszentrum für Klinische Studien - Duesseldorf
Conditions Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Enrollment 38 participants
Start Date 2023-06-26
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-16