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Venetoclax Registry (VENreg)

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ClinicalTrials.gov Identifier: NCT03662724
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Tracking Information
First Submitted Date September 4, 2018
First Posted Date September 7, 2018
Last Update Posted Date February 1, 2019
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03662724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 6, 2018)
  • Event-free survival during Venetoclax treatment [ Time Frame: 5 years ]
    Event-free survival of patients with relapsed/refractory AML receiving Venetoclax
  • Relapse-free survival during Venetoclax treatment [ Time Frame: 5 years ]
    Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax
  • Overall survival during Venetoclax treatment [ Time Frame: 5 years ]
    Overall survival of patients with relapsed/refractory AML receiving Venetoclax
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Venetoclax Registry
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
Brief Summary Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Samples with DNA (either bone marrow or peripheral blood)
Sampling Method Non-Probability Sample
Study Population Patiens with relapsed/refractory AML including patients who received stem cell transplantation.
Condition Acute Myeloid Leukemia
Intervention Drug: Venetoclax
Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.
Other Name: Venclyxto
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2025
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michael Heuser, MD +49511 5323720 heuser.michael@mh-hannover.de
Contact: Rabia Shahswar, MD +49511 5329575 shahswar.rabia@mh-hannover.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03662724
Other Study ID Numbers 7972_BO_K_2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hannover Medical School
Study Sponsor Hannover Medical School
Collaborators Not Provided
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
PRS Account Hannover Medical School
Verification Date September 2018