Status:
RECRUITING
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Acute Leukemia French Association
Conditions:
AML, Adult
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy
- Treatment in the named-patients program (ATU)
Exclusion
- 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
Key Trial Info
Start Date :
July 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06263387
Start Date
July 4 2024
End Date
March 30 2025
Last Update
July 23 2024
Active Locations (42)
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1
Amiens CHU
Amiens, France
2
Angers CHU
Angers, France
3
Avignon CH
Avignon, France
4
Bayonne CH
Bayonne, France