Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FL
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)
| Condition(s) | Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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) |
| Who can participate | Inclusion Criteria: * Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC), prior to the initiation of any study-specific procedures * MDS, CMML or sAML according to WHO classification (revised version 2016) with a marrow blast count \>5% and/or high-risk genetic features (e.g. 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 * Untreated except for oral Hydroxyurea or a maximum of 2 courses of treatment with Azacytidine or Decitabi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Heinrich-Heine University, Duesseldorf |
| Locations | Aachen, North Rhine-Westphalia, Germany; Düsseldorf, North Rhine-Westphalia, Germany; Cologne, Germany; Frankfurt, Germany; Jena, Germany; München, Germany |
| Start date | 2023-06-26 |
| NCT ID | NCT05807932 |
| Official listing | https://clinicaltrials.gov/study/NCT05807932 |