NCT03662724

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

September 4, 2018

Last Update Submit

February 15, 2021

Conditions

Acute Myeloid Leukemia

Keywords

Relapsed/refractory adult acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes (1)

  • Overall response rate of Venetoclax treatment.

    Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)

    4 months

Secondary Outcomes (3)

  • Event-free survival during Venetoclax treatment

    5 years

  • Relapse-free survival during Venetoclax treatment

    5 years

  • Overall survival during Venetoclax treatment

    5 years

Interventions

VenetoclaxDRUG

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

Also known as: Venclyxto

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patiens with relapsed/refractory AML including patients who received stem cell transplantation.

You may qualify if:

  • relapsed/refractory AML

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA (either bone marrow or peripheral blood)

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Michael Heuser, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Rabia Shahswar, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Gernot Beutel, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Heuser, MD

CONTACT

+49511 5323720heuser.michael@mh-hannover.de

Rabia Shahswar, MD

CONTACT

+49511 5329575shahswar.rabia@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 7, 2018

Study Start

November 1, 2017

Primary Completion

November 1, 2021

Study Completion

November 1, 2025

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

DE(1)