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

• Conditions: MedDRA version: 20.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 100000004864; Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or secondary acute myeloid leukemia (sAML) before stem cell transplantation; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2022-002435-66-DE
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf represented by the Coordinating Investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

MDS, CMML or sAML (marrow blast count <30%) according to WHO classification (revised version 2016) with a marrow blast count >5% and 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), or a marrow blast count >20% any time between diagnosis and inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

previous cytotoxic therapy exceeding oral Hydroxyurea >60 days or >2 courses of treatment with Azacytidine or Decitabine alone or in combination with Venetoclax

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified