Venetoclax Registry
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT03662724
- Lead Sponsor
- Hannover Medical School
- Brief Summary
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax
- Detailed Description
The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study.
1. Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
2. Collection and integrative analysis of clinical data of included patients.
3. Mutation analysis of available patient samples and correlation with clinical parameters.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
relapsed/refractory AML
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate of Venetoclax treatment. 4 months Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)
- Secondary Outcome Measures
Name Time Method Overall survival during Venetoclax treatment 5 years Overall survival of patients with relapsed/refractory AML receiving Venetoclax
Event-free survival during Venetoclax treatment 5 years Event-free survival of patients with relapsed/refractory AML receiving Venetoclax
Relapse-free survival during Venetoclax treatment 5 years Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax
Trial Locations
- Locations (1)
Medical School Hannover
🇩🇪Hannover, Niedersachsen, Germany