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Trial record 4 of 200 for:    Venetoclax

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

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
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 : November 1, 2017
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2025



Intervention Details:
  • Drug: Venetoclax
    Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.
    Other Name: Venclyxto


Primary Outcome Measures :
  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 Measures :
  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


Biospecimen Retention:   Samples With DNA
Samples with DNA (either bone marrow or peripheral blood)


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patiens with relapsed/refractory AML including patients who received stem cell transplantation.
Criteria

Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662724


Contacts
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Contact: Michael Heuser, MD +49511 5323720 heuser.michael@mh-hannover.de
Contact: Rabia Shahswar, MD +49511 5329575 shahswar.rabia@mh-hannover.de

Locations
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Germany
Medical School Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Michael Heuser, MD    +49511 5323720    heuser.michael@mh-hannover.de   
Contact: Rabia Shahswar, MD    +49511 5329575    shahswar.rabia@mh-hannover.de   
Principal Investigator: Michael Heuser, MD         
Principal Investigator: Rabia Shahswar, MD         
Principal Investigator: Gernot Beutel, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Michael Heuser, MD Hannover Medical School
Principal Investigator: Rabia Shahswar, MD Hannover Medical School
Principal Investigator: Gernot Beutel, MD Hannover Medical School

Additional Information:

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03662724     History of Changes
Other Study ID Numbers: 7972_BO_K_2018
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: September 2018

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Venetoclax
Antineoplastic Agents