Venetoclax Registry

Acute Myeloid Leukemia Clinical Trial

— VENreg  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662724
• Other study ID #: 7972_BO_K_2018
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2021
• Source: Hannover Medical School
• Contact: Michael Heuser, MD
• Phone: +49511 5323720
• Email: heuser.michael[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax
Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate of Venetoclax treatment.	Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)	4 months
Secondary	Event-free survival during Venetoclax treatment	Event-free survival of patients with relapsed/refractory AML receiving Venetoclax	5 years
Secondary	Relapse-free survival during Venetoclax treatment	Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax	5 years
Secondary	Overall survival during Venetoclax treatment	Overall survival of patients with relapsed/refractory AML receiving Venetoclax	5 years