Acute Myeloid LeukemiaVENregNCT03662724
Venetoclax Registry
An observational study of Acute Myeloid Leukemia, run by Hannover Medical School at 1 site in Germany.
Trial summary
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 1 Nov 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patiens with relapsed/refractory AML including patients who received stem cell transplantation.
Who may be able to join
- relapsed/refractory AML
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical School Hannover
Hanover, Lower Saxony, 30625
Michael Heuser, MD, +49511 5323720, heuser.michael@mh-hannover.de
Rabia Shahswar, MD, +49511 5329575, shahswar.rabia@mh-hannover.de
About this study
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
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax
Read the 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.
- Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
- Collection and integrative analysis of clinical data of included patients.
- Mutation analysis of available patient samples and correlation with clinical parameters.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax
- Keywords
- Relapsed/refractory adult acute myeloid leukemia (AML)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called Venclyxto
Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate of Venetoclax treatment.
Overall response rate of Venetoclax treatment (complete remission, complete remission with incomplete regeneration, partial remission)
Measured: 4 months
Secondary outcomes (3)
Event-free survival during Venetoclax treatment
Event-free survival of patients with relapsed/refractory AML receiving Venetoclax
Measured: 5 years
Relapse-free survival during Venetoclax treatment
Relapse-free survival of patients with relapsed/refractory AML receiving Venetoclax
Measured: 5 years
Overall survival during Venetoclax treatment
Overall survival of patients with relapsed/refractory AML receiving Venetoclax
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Nov 2017
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Heuser, MD, Principal investigator, Hannover Medical SchoolRabia Shahswar, MD, Principal investigator, Hannover Medical SchoolGernot Beutel, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662724
- Sponsor's protocol ID
- 7972_BO_K_2018
- Acronym
- VENreg
- Status last verified
- Feb 2021
- First submitted
- 4 Sep 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03662724
- Acronym / sponsor ID
- VENreg / 7972_BO_K_2018
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Relapsed/refractory adult acute myeloid leukemia (AML)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
- Collection and integrative analysis of clinical data of included patients.
- Mutation analysis of available patient samples and correlation with clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patiens with relapsed/refractory AML including patients who received stem cell transplantation.
Key inclusion criteria (1 listed)
- relapsed/refractory AML
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: VenclyxtoRegistry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax. | Drug | – |
Primary outcome
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)
3 secondary outcomes
Event-free survival during Venetoclax treatment
Time frame: 5 years
Relapse-free survival during Venetoclax treatment
Time frame: 5 years
Overall survival during Venetoclax treatment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
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RecruitingPhase 2
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Heuser, MD principal investigator
Hannover Medical School
Rabia Shahswar, MD principal investigator
Hannover Medical School
Gernot Beutel, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Heuser, MD (+49511 5323720, heuser.michael@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate of Venetoclax treatment. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.