VENreg: Venetoclax Registry

• Sponsor: Hannover Medical School (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03662724
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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: Nov 1, 2017
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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

1. Event-free survival during Venetoclax treatment [5 years]

   Event-free survival of patients with relapsed/refractory AML receiving Venetoclax

2. Relapse-free survival during Venetoclax treatment [5 years]

   Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax

3. Overall survival during Venetoclax treatment [5 years]

   Overall survival of patients with relapsed/refractory AML receiving Venetoclax

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical School Hannover	Hannover	Niedersachsen	Germany	30625

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hannover Medical School
• ClinicalTrials.gov Identifier: NCT03662724
• Other Study ID Numbers: 7972_BO_K_2018
• First Posted: Sep 7, 2018
• Last Update Posted: Feb 16, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hannover Medical School: Relapsed/refractory adult acute myeloid leukemia (AML)
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Venetoclax

Study Results

No Results Posted as of Feb 16, 2021