Acute Myeloid LeukemiaVENAURANCT06429670
Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory
An observational study of Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 500 participants
- Where
- 12 sitesFrance
- Study dates
- 1 May 2023to 1 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every adult patients ( >18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.
Who may be able to join
- >18 years old
- Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
- receiving AZA/VEN combination regimen
Who cannot join
- Another VEN combination chemotherapy
- AZA/VEN initiation prior January 2019 and after December 2023
- Opposition to the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord
Bourgoin, 38300
METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
Chambéry, 73000
CHU Clermont-Ferrand Site Estaing
Clermont-Ferrand, 63100
Centre Hospitalier Annecy Genevois
Épagny, 74370
CHU Grenoble Alpes
La Tronche
Centre Léon Bérard
Lyon, 69003
Hospices Civils de Lyon
Lyon, 69229
Centre Hospitalier de Roanne
Roanne, 42300
CHU de Saint-Étienne Hôpital Nord
Saint-Priest-en-Jarez, 42270
Centre Hospitalier de Valence
Valence, 26000
Ch de Valence
Valence
Hopital Vichy
Vichy, 03200
About this study
Official title: Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group
Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, azacitdine, venetoclax, MRD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Azacytidine and venetoclax treated patients | Adult patients with acute myeloid leukemia treated by AZACYTIDINE and VENETOCLAX in frontline and relapse/refractory settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 May 2023
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429670
- Sponsor's protocol ID
- 69HCL24_0521
- Acronym
- VENAURA
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group
- ClinicalTrials.gov ID
- NCT06429670
- Acronym / sponsor ID
- VENAURA / 69HCL24_0521
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, azacitdine, venetoclax, MRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 May 2024 (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.
Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacytidine and venetoclax treated patients | – | –Adult patients with acute myeloid leukemia treated by AZACYTIDINE and VENETOCLAX in frontline and relapse/refractory settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every adult patients ( >18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.
Key inclusion criteria (3 listed)
- >18 years old
- Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
- receiving AZA/VEN combination regimen
Key exclusion criteria (3 listed)
- Another VEN combination chemotherapy
- AZA/VEN initiation prior January 2019 and after December 2023
- Opposition to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: up to 5 months
Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites 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 Hospices Civils de Lyon at 12 sites in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 5 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 28 May 2024.