- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263387
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine (VENAZA)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ariane MINEUR
- Phone Number: +33 (0)5 57 62 31 08
- Email: ariane.mineur@chu-bordeaux.fr
Study Locations
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Amiens, France
- Amiens CHU
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Angers, France
- Angers CHU
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Avignon, France
- Avignon CH
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Bayonne, France
- Bayonne CH
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Besançon, France
- Besançon CHU
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Brest, France
- Brest CHU
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Caen, France
- Caen CHU
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Cergy-Pontoise, France
- CERGY PONTOISE - CH René Dubos
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Clamart, France
- Hôpital d'Instruction des Armées PERCY
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Clermont-Ferrand, France
- CHU Estaing
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Corbeil-Essonnes, France
- Corbeil-Essonnes - Ch Sud Francilien
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Créteil, France
- Créteil CHU HENRI MONDOR
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Dijon, France
- Dijon CHU
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Grenoble, France
- Grenoble CHU
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Le Mans, France
- Le Mans CH
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Lille, France
- CHU Lille
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Limoges, France
- Limoges CHU
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Lyon, France
- Lyon sud CHU
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Marseille, France
- Marseille IPC
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Meaux, France
- Meaux CH de l'Est francilien
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Metz, France
- METZ-THIONVILLE CHR- Hôpital de Mercy
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Montpellier, France
- Montpellier - Chu Saint Eloi
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Nantes, France
- Nantes CHU
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Nice, France
- Nice CHU
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Nîmes, France
- Nimes CHU
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Paris, France
- Paris Necker
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Paris, France
- Paris Saint Louis
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Paris, France
- Paris La Pitié salpetrière
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Pessac, France
- Bordeaux CHU
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Reims, France
- Reims Chu
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Rennes, France
- Rennes CHU
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Roubaix, France
- roubaix CH
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Rouen, France
- Centre de Lutte Contre le Cancer H. Becquerel
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Saint-Priest-en-Jarez, France
- Institut de Cancérologie Lucien Neuwirth
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Saint-Quentin, France
- Saint Quentin CH
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Strasbourg, France
- ICANS - Institut de Cancérologie de Strasbourg Europe
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Toulouse, France
- Toulouse - IUCT Oncopole - Service d'Hématologie
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Tours, France
- Tours CHU
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Troyes, France
- Troyes CH
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Versailles, France
- Versailles CH
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Villejuif, France
- Villejuif IGR
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vandoeuvre les Nancy, France
- Nancy CHU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy
- Treatment in the named-patients program (ATU)
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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18 months (since Cycle 1 Day 1)
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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)
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rate of OS according to the 2022 European LeukemiaNet (ELN)
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18 months (since Cycle 1 Day 1)
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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)
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rate of EFS according to the 2022 European LeukemiaNet (ELN)
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18 months (since Cycle 1 Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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description of grade 3/4 SAE and death according to CTCAE v5.
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18 months (since Cycle 1 Day 1)
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describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient.
Time Frame: 18 months (since Cycle 1 Day 1)
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daily dose and duration of Venetoclax and Azacitidine description of Venetoclax and Azacitidine dose modification description of Venetoclax and Azacitidine duration
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18 months (since Cycle 1 Day 1)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sylvain GARCIAZ, MD-PhD, French Innovative Leukemia Organisation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FILObsLAM_VENAZA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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