AML, AdultVENAZANCT06263387
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
An observational study of AML, Adult, run by French Innovative Leukemia Organisation at 42 sites in France.
Trial summary
Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- How many people
- 230 participants
- Where
- 42 sitesFrance
- Study dates
- 4 Jul 2024to 30 Mar 2025
- How long will I take part?
- 18 Months
- 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: Adult Patients with de novo AML, ineligible for intensive chemotherapy, which received VENAZA in the ATU program between 02/15/2021 and 06/30/2021
Who may be able to join
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy
- Treatment in the named-patients program (ATU)
Who cannot join
- Treatment with VEN-AZA for previously treated AML
- Prior treatment for preexisting hematological malignancies other that AML, including AZA is not an exclusion criteria
- HYDROXYCARBAMIDE given for AML is not an exclusion criteria
- AZA started before VEN for AML is not an exclusion criteria
- Opposition to data collection
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
France42 sites, 42 recruiting
- Not yet recruiting
Amiens CHU
Amiens
Delphine Lebon, Dr, lebon.delphine@chu-amiens.fr
- Not yet recruiting
Angers CHU
Angers
Mathilde Hunault, Prof, mahunault@chu-angers.fr
- Not yet recruiting
Avignon CH
Avignon
Safia Chebrek, dr, chebrek.safia@ch-avignon.fr
- Not yet recruiting
Bayonne CH
Bayonne
Anne Banos, Dr, abanos@ch-cotebasque.fr
- Recruiting
Besançon CHU
Besançon
Yohann Desbrosses, Dr, ydesbrosses@chu-besancon.fr
- Not yet recruiting
Brest CHU
Brest
Gaelle Guillerm, Dr, gaelle.guillerm@chu-brest.fr
- Not yet recruiting
Caen CHU
Caen
sylvain Chantepie, Dr, chantepie-s@chu-caen.fr
- Not yet recruiting
CERGY PONTOISE - CH René Dubos
Cergy-Pontoise
ioana Vaida, Dr, ioana.vaida@ght-novo.fr
- Not yet recruiting
Hôpital d'Instruction des Armées PERCY
Clamart
Pierre Arnautou, Dr, pierre.arnautou@intradef.gouv.fr
- Not yet recruiting
CHU Estaing
Clermont-Ferrand
Gaspar Aspas Requena, MD, gaspasrequena@chu-clermontferrand.fr
- Not yet recruiting
Corbeil-Essonnes - Ch Sud Francilien
Corbeil-Essonnes
Stephanie Haiat, Dr, stephanie.haiat@chsf.fr
- Not yet recruiting
Créteil CHU HENRI MONDOR
Créteil
Cécile Pautas, Dr, cecile.pautas@aphp.fr
- Not yet recruiting
Dijon CHU
Dijon
Marie-Lorraine chretien, Dr, marie-lorraine.chretien@chu-dijon.fr
- Not yet recruiting
Grenoble CHU
Grenoble
Martin Carré, Dr, MCarre1@chu-grenoble.fr
- Not yet recruiting
Le Mans CH
Le Mans
Kamel Laribi, Dr, klaribi@ch-lemans.fr
- Not yet recruiting
CHU Lille
Lille
Céline Berthon, Dr, celine.berthon@chu-lille.fr
- Not yet recruiting
Limoges CHU
Limoges
Pascal Turlure, Dr, pascal.turlure@chu-limoges.fr
- Not yet recruiting
Lyon sud CHU
Lyon
Mael Heiblig, Pr, mael.heiblig@chu-lyon.fr
- Not yet recruiting
Marseille IPC
Marseille
Sylvain GARCIAZ, Dr, GARCIAZS@ipc.unicancer.fr
- Not yet recruiting
Meaux CH de l'Est francilien
Meaux
Jamilé Frayfer, Dr, jfrayfer@ghef.fr
- Not yet recruiting
METZ-THIONVILLE CHR- Hôpital de Mercy
Metz
Houria Debarri, Dr, h.debarri@chr-metz-thionville.fr
- Not yet recruiting
Montpellier - Chu Saint Eloi
Montpellier
Ludovic Gabellier, Dr, l-gabellier@chu-montpellier.fr
- Not yet recruiting
Nantes CHU
Nantes
Pierre Peterlin, Dr, pierre.peterlin@chu-nantes.fr
- Not yet recruiting
Nice CHU
Nice
Thomas Cluzeau, Prof, cluzeau.t@chu-nice.fr
- Not yet recruiting
Nimes CHU
Nîmes
Eric Jourdan, Dr, eric.jourdan@chu-nimes.fr
- Not yet recruiting
Paris La Pitié salpetrière
Paris
Madalina Uzunov, Dr, madalina.uzunov@psl.aphp.fr
- Not yet recruiting
Paris Necker
Paris
Ambroise Marcais, Dr, ambroise.marcais@aphp.fr
- Not yet recruiting
Paris Saint Louis
Paris
Emmanuel Raffoux, Prof, emmanuel.raffoux@aphp.fr
- Recruiting
Bordeaux CHU
Pessac
Pierre-Yves Dumas, Prof, pierre-yves.dumas@chu-bordeaux.fr
- Not yet recruiting
Reims CHU
Reims
Chantal Himberlin, Dr, chimberlin@chu-reims.fr
- Not yet recruiting
Rennes CHU
Rennes
tony Marchand, Dr, tony.marchand@chu-rennes.fr
- Not yet recruiting
roubaix CH
Roubaix
Mathieu Wemeau, Dr, mathieu.wemeau@ch-roubaix.fr
- Not yet recruiting
Centre de Lutte Contre le Cancer H. Becquerel
Rouen
Emilie Lemasle, Dr, emilie.lemasle@chb.unicancer.fr
- Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Emmanuelle tavernier, Dr, emmanuelle.tavernier@icloire.fr
- Not yet recruiting
Saint Quentin CH
Saint-Quentin
reda Garidi, Dr, r.garidi@ch-stquentin.fr
- Not yet recruiting
ICANS - Institut de cancérologie de strasbourg europe
Strasbourg
Célestine Simand, Dr, c.simand@icans.eu
- Recruiting
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse
Toulouse - IUCT Oncopole - S d'Hématologie, Pr, recher.christian@iuct-oncopole.fr
- Not yet recruiting
Tours CHU
Tours
Alban Villate, Dr, a.villate@chu-tours.fr
- Not yet recruiting
Troyes CH
Troyes
Alberto santagostino, Dr, alberto.santagostino@ch-troyes.fr
- Not yet recruiting
Nancy CHU
Vandœuvre-lès-Nancy
Caroline Bonmati, Dr, c.bonmati@chu-nancy.fr
- Not yet recruiting
Versailles CH
Versailles
Juliette Lambert, Dr, jlambert@ch-versailles.fr
- Not yet recruiting
Villejuif IGR
Villejuif
Florence Pasquier, Dr, florence.pasquier@gustaveroussy.fr
About this study
Official title: Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine
Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.
Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition.
- Conditions
- AML, Adult
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
- Rate of complete remission and complete remission with incomplete hematologic recovery (CR/CRi),
- Rate of morphological leukemia free state (MLFS)
- Rate of CR/CRi rate with negative minimal residual disease (MRD) assessed by flow cytometry (FCT) and/or molecular techniques if available
Measured: 18 months (since Cycle 1 Day 1)
characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
rate of OS according to the 2022 European LeukemiaNet (ELN)
Measured: 18 months (since Cycle 1 Day 1)
characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
rate of EFS according to the 2022 European LeukemiaNet (ELN)
Measured: 18 months (since Cycle 1 Day 1)
Secondary outcomes (2)
characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life
description of grade 3/4 SAE and death according to CTCAE v5.
Measured: 18 months (since Cycle 1 Day 1)
describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient.
daily dose and duration of Venetoclax and Azacitidine description of Venetoclax and Azacitidine dose modification description of Venetoclax and Azacitidine duration
Measured: 18 months (since Cycle 1 Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start4 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies 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
- Cross-sectional
- Enrolment
- 230 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Acute Leukemia French Association
- Responsible party
- Sponsor
- Investigators
- Sylvain GARCIAZ, MD-PhD, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263387
- Sponsor's protocol ID
- FILObsLAM_VENAZA
- Acronym
- VENAZA
- Status last verified
- Jul 2024
- First submitted
- 14 Dec 2023
- Last updated
- 23 Jul 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine
- ClinicalTrials.gov ID
- NCT06263387
- Acronym / sponsor ID
- VENAZA / FILObsLAM_VENAZA
- Conditions
- AML, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Acute Leukemia French Association
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 16 Feb 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.
Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.
Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients with de novo AML, ineligible for intensive chemotherapy, which received VENAZA in the ATU program between 02/15/2021 and 06/30/2021
Key inclusion criteria (3 listed)
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy
- Treatment in the named-patients program (ATU)
Key exclusion criteria (5 listed)
- Treatment with VEN-AZA for previously treated AML
- Opposition to data collection
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
characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
Time frame: 18 months (since Cycle 1 Day 1)
1. Rate of complete remission and complete remission with incomplete hematologic recovery (CR/CRi), 2. Rate of morphological leukemia free state (MLFS) 3. Rate of CR/CRi rate with negative minimal residual disease (MRD) assessed by flow cytometry (FCT) and/or molecular techniques if available
characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
Time frame: 18 months (since Cycle 1 Day 1)
rate of OS according to the 2022 European LeukemiaNet (ELN)
characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort
Time frame: 18 months (since Cycle 1 Day 1)
rate of EFS according to the 2022 European LeukemiaNet (ELN)
2 secondary outcomes
characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life
Time frame: 18 months (since Cycle 1 Day 1)
describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient.
Time frame: 18 months (since Cycle 1 Day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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.
Sylvain GARCIAZ, MD-PhD principal investigator
French Innovative Leukemia Organisation
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, Adult, run by French Innovative Leukemia Organisation at 42 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 5 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane MINEUR (+33 (0)5 57 62 31 08, ariane.mineur@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort (time frame: 18 months (since Cycle 1 Day 1)). The study lists 3 primary outcomes in all. 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 23 Jul 2024.