Trial Title:
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
NCT ID:
NCT06263387
Condition:
AML, Adult
Conditions: Official terms:
Leukemia, Myeloid, Acute
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amiens CHU
Address:
City:
Amiens
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Delphine Lebon, Dr
Email:
lebon.delphine@chu-amiens.fr
Facility:
Name:
Angers CHU
Address:
City:
Angers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mathilde Hunault, Prof
Email:
mahunault@chu-angers.fr
Facility:
Name:
Avignon CH
Address:
City:
Avignon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Safia Chebrek, dr
Email:
chebrek.safia@ch-avignon.fr
Facility:
Name:
Bayonne CH
Address:
City:
Bayonne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne Banos, Dr
Email:
abanos@ch-cotebasque.fr
Facility:
Name:
Besançon CHU
Address:
City:
Besançon
Country:
France
Status:
Recruiting
Contact:
Last name:
Yohann Desbrosses, Dr
Email:
ydesbrosses@chu-besancon.fr
Facility:
Name:
Brest CHU
Address:
City:
Brest
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gaelle Guillerm, Dr
Email:
gaelle.guillerm@chu-brest.fr
Facility:
Name:
Caen CHU
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
sylvain Chantepie, Dr
Email:
chantepie-s@chu-caen.fr
Facility:
Name:
CERGY PONTOISE - CH René Dubos
Address:
City:
Cergy-Pontoise
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
ioana Vaida, Dr
Email:
ioana.vaida@ght-novo.fr
Facility:
Name:
Hôpital d'Instruction des Armées PERCY
Address:
City:
Clamart
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre Arnautou, Dr
Email:
pierre.arnautou@intradef.gouv.fr
Facility:
Name:
CHU Estaing
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gaspar Aspas Requena, MD
Email:
gaspasrequena@chu-clermontferrand.fr
Facility:
Name:
Corbeil-Essonnes - Ch Sud Francilien
Address:
City:
Corbeil-Essonnes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Stephanie Haiat, Dr
Email:
stephanie.haiat@chsf.fr
Facility:
Name:
Créteil CHU HENRI MONDOR
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cécile Pautas, Dr
Email:
cecile.pautas@aphp.fr
Facility:
Name:
Dijon CHU
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie-Lorraine chretien, Dr
Email:
marie-lorraine.chretien@chu-dijon.fr
Facility:
Name:
Grenoble CHU
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Martin Carré, Dr
Email:
MCarre1@chu-grenoble.fr
Facility:
Name:
Le Mans CH
Address:
City:
Le Mans
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Kamel Laribi, Dr
Email:
klaribi@ch-lemans.fr
Facility:
Name:
CHU Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Céline Berthon, Dr
Email:
celine.berthon@chu-lille.fr
Facility:
Name:
Limoges CHU
Address:
City:
Limoges
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pascal Turlure, Dr
Email:
pascal.turlure@chu-limoges.fr
Facility:
Name:
Lyon sud CHU
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mael Heiblig, Pr
Email:
mael.heiblig@chu-lyon.fr
Facility:
Name:
Marseille IPC
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sylvain GARCIAZ, Dr
Email:
GARCIAZS@ipc.unicancer.fr
Facility:
Name:
Meaux CH de l'Est francilien
Address:
City:
Meaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jamilé Frayfer, Dr
Email:
jfrayfer@ghef.fr
Facility:
Name:
METZ-THIONVILLE CHR- Hôpital de Mercy
Address:
City:
Metz
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Houria Debarri, Dr
Email:
h.debarri@chr-metz-thionville.fr
Facility:
Name:
Montpellier - Chu Saint Eloi
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ludovic Gabellier, Dr
Email:
l-gabellier@chu-montpellier.fr
Facility:
Name:
Nantes CHU
Address:
City:
Nantes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre Peterlin, Dr
Email:
pierre.peterlin@chu-nantes.fr
Facility:
Name:
Nice CHU
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thomas Cluzeau, Prof
Email:
cluzeau.t@chu-nice.fr
Facility:
Name:
Nimes CHU
Address:
City:
Nîmes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric Jourdan, Dr
Email:
eric.jourdan@chu-nimes.fr
Facility:
Name:
Paris La Pitié salpetrière
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Madalina Uzunov, Dr
Email:
madalina.uzunov@psl.aphp.fr
Facility:
Name:
Paris Necker
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ambroise Marcais, Dr
Email:
ambroise.marcais@aphp.fr
Facility:
Name:
Paris Saint Louis
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emmanuel Raffoux, Prof
Email:
emmanuel.raffoux@aphp.fr
Facility:
Name:
Bordeaux CHU
Address:
City:
Pessac
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre-Yves Dumas, Prof
Email:
pierre-yves.dumas@chu-bordeaux.fr
Facility:
Name:
Reims CHU
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Chantal Himberlin, Dr
Email:
chimberlin@chu-reims.fr
Facility:
Name:
Rennes CHU
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
tony Marchand, Dr
Email:
tony.marchand@chu-rennes.fr
Facility:
Name:
roubaix CH
Address:
City:
Roubaix
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mathieu Wemeau, Dr
Email:
mathieu.wemeau@ch-roubaix.fr
Facility:
Name:
Centre de Lutte Contre le Cancer H. Becquerel
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emilie Lemasle, Dr
Email:
emilie.lemasle@chb.unicancer.fr
Facility:
Name:
Institut de Cancérologie Lucien Neuwirth
Address:
City:
Saint-Priest-en-Jarez
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuelle tavernier, Dr
Email:
emmanuelle.tavernier@icloire.fr
Facility:
Name:
Saint Quentin CH
Address:
City:
Saint-Quentin
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
reda Garidi, Dr
Email:
r.garidi@ch-stquentin.fr
Facility:
Name:
ICANS - Institut de cancérologie de strasbourg europe
Address:
City:
Strasbourg
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Célestine Simand, Dr
Email:
c.simand@icans.eu
Facility:
Name:
Toulouse - IUCT Oncopole - Service d'Hématologie
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Toulouse - IUCT Oncopole - S d'Hématologie, Pr
Email:
recher.christian@iuct-oncopole.fr
Facility:
Name:
Tours CHU
Address:
City:
Tours
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alban Villate, Dr
Email:
a.villate@chu-tours.fr
Facility:
Name:
Troyes CH
Address:
City:
Troyes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alberto santagostino, Dr
Email:
alberto.santagostino@ch-troyes.fr
Facility:
Name:
Nancy CHU
Address:
City:
vandoeuvre les Nancy
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Caroline Bonmati, Dr
Email:
c.bonmati@chu-nancy.fr
Facility:
Name:
Versailles CH
Address:
City:
Versailles
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Juliette Lambert, Dr
Email:
jlambert@ch-versailles.fr
Facility:
Name:
Villejuif IGR
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florence Pasquier, Dr
Email:
florence.pasquier@gustaveroussy.fr
Start date:
July 4, 2024
Completion date:
March 30, 2025
Lead sponsor:
Agency:
French Innovative Leukemia Organisation
Agency class:
Other
Collaborator:
Agency:
Acute Leukemia French Association
Agency class:
Other
Source:
French Innovative Leukemia Organisation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263387
