Venetoclax Registry

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03662724

Studienbeginn:
November 2017

Letztes Update:
16.02.2021

Wirkstoff:
Venetoclax

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Hannover Medical School

Collaborator:
-

Studienleiter

Michael Heuser, MD
Principal Investigator
Hannover Medical School

Rabia Shahswar, MD
Principal Investigator
Hannover Medical School

Gernot Beutel, MD
Principal Investigator
Hannover Medical School

Kontakt

Michael Heuser, MD
Kontakt:
Phone: +49511 5323720
E-Mail: heuser.michael@mh-hannover.de» Kontaktdaten anzeigen

Rabia Shahswar, MD
Kontakt:
Phone: +49511 5329575
E-Mail: shahswar.rabia@mh-hannover.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical School Hannover
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Michael Heuser, MD
Phone: +49511 5323720
E-Mail: heuser.michael@mh-hannover.de

Rabia Shahswar, MD
Phone: +49511 5329575
E-Mail: shahswar.rabia@mh-hannover.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-

Studien-Rationale

Primary outcome:

1. 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)

Secondary outcome:

1. Event-free survival during Venetoclax treatment (Time Frame - 5 years):
Event-free survival of patients with relapsed/refractory AML receiving Venetoclax

2. Relapse-free survival during Venetoclax treatment (Time Frame - 5 years):
Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax

3. Overall survival during Venetoclax treatment (Time Frame - 5 years):
Overall survival of patients with relapsed/refractory AML receiving Venetoclax

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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