Venetoclax Registry

NCT ID: NCT03662724

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Venetoclax

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

Intervention Type DRUG

Other Intervention Names

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Venclyxto

Eligibility Criteria

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Inclusion Criteria

relapsed/refractory AML

Exclusion Criteria

\-
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Heuser, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Rabia Shahswar, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Gernot Beutel, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Medical School Hannover

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Heuser, MD

Role: CONTACT

+49511 5323720

Rabia Shahswar, MD

Role: CONTACT

+49511 5329575

Facility Contacts

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Michael Heuser, MD

Role: primary

+49511 5323720

Rabia Shahswar, MD

Role: backup

+49511 5329575

Other Identifiers

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7972_BO_K_2018

Identifier Type: -

Identifier Source: org_study_id

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