Venetoclax Registry (VENreg)

February 15, 2021 updated by: Hannover Medical School

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medical School Hannover
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Heuser, MD
        • Principal Investigator:
          • Rabia Shahswar, MD
        • Principal Investigator:
          • Gernot Beutel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patiens with relapsed/refractory AML including patients who received stem cell transplantation.

Description

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival during Venetoclax treatment
Time Frame: 5 years
Event-free survival of patients with relapsed/refractory AML receiving Venetoclax
5 years
Relapse-free survival during Venetoclax treatment
Time Frame: 5 years
Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax
5 years
Overall survival during Venetoclax treatment
Time Frame: 5 years
Overall survival of patients with relapsed/refractory AML receiving Venetoclax
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Michael Heuser, MD, Hannover Medical School
  • Principal Investigator: Rabia Shahswar, MD, Hannover Medical School
  • Principal Investigator: Gernot Beutel, MD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2025

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (ACTUAL)

September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7972_BO_K_2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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