Venetoclax Registry (VENreg)
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|ClinicalTrials.gov Identifier: NCT03662724|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia||Drug: Venetoclax|
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.
- Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
- Collection and integrative analysis of clinical data of included patients.
- Mutation analysis of available patient samples and correlation with clinical parameters.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax: The Venetoclax Registry|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2025|
- Drug: Venetoclax
Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.Other Name: Venclyxto
- Overall response rate of Venetoclax treatment. [ Time Frame: 4 months ]Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)
- Event-free survival during Venetoclax treatment [ Time Frame: 5 years ]Event-free survival of patients with relapsed/refractory AML receiving Venetoclax
- Relapse-free survival during Venetoclax treatment [ Time Frame: 5 years ]Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax
- Overall survival during Venetoclax treatment [ Time Frame: 5 years ]Overall survival of patients with relapsed/refractory AML receiving Venetoclax
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662724
|Medical School Hannover|
|Hannover, Niedersachsen, Germany, 30625|
|Principal Investigator:||Michael Heuser, MD||Hannover Medical School|
|Principal Investigator:||Rabia Shahswar, MD||Hannover Medical School|
|Principal Investigator:||Gernot Beutel, MD||Hannover Medical School|