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 transplantatio
Phase 1
Recruiting
- Conditions
- Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or secondary acute myeloid leukemia (sAML) before stem cell transplantationMedDRA version: 20.1Level: LLTClassification code: 10024329Term: Leukemia Class: 10029104Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-514688-24-00
- Lead Sponsor
- Heinrich-Heine-Universitaet Duesseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
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.
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method