Acute Myeloid Leukemia
Conditions
Keywords
Relapsed/refractory adult acute myeloid leukemia (AML)
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.
Interventions
DRUGVenetoclax
Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
relapsed/refractory AML
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate of Venetoclax treatment. | 4 months | Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival during Venetoclax treatment | 5 years | Overall survival of patients with relapsed/refractory AML receiving Venetoclax |
Countries
Germany
Contacts
Primary ContactMichael Heuser, MD
Backup ContactRabia Shahswar, MD
Outcome results
None listed