Clinical trial • Phase I • Oncology
Azacitidine for Acute myeloid leukemia|Myelodysplastic syndrome
Phase I trial of Azacitidine for Acute myeloid leukemia|Myelodysplastic syndrome. 70 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukemia|Myelodysplastic syndrome
- Trial Stage
- Phase I
- Drug Modality
- Other|Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-06-2025
- First CTIS Authorization Date
- 26-09-2025
Trial design
Phase I trial across 5 sites in France, Spain.
- Target Sample Size
- 70
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 37
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 35
France
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 213
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie
- Principal Investigator Name
- Emmanuel RAFFOUX
- Principal Investigator Email
- emmanuel.raffoux@aphp.fr
- Contact Person Name
- Emmanuel RAFFOUX
- Contact Person Email
- emmanuel.raffoux@aphp.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Hématologie
- Principal Investigator Name
- Christian RECHER
- Principal Investigator Email
- recher.christian@iuct-oncopole.fr
- Contact Person Name
- Christian RECHER
- Contact Person Email
- recher.christian@iuct-oncopole.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Hématologie IPC4
- Principal Investigator Name
- Sylvain GARCIAZ
- Principal Investigator Email
- garciazs@ipc.unicancer.fr
- Contact Person Name
- Sylvain GARCIAZ
- Contact Person Email
- garciazs@ipc.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 04-09-2025
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 104
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Principal Investigator Name
- Eduardo Rodriguez Arboli
- Principal Investigator Email
- XXXX@XXXX.XX
- Contact Person Name
- Eduardo Rodriguez Arboli
- Contact Person Email
- XXXX@XXXX.XX
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Jordi Esteve Reyner
- Principal Investigator Email
- jesteve@clinic.cat
- Contact Person Name
- Jordi Esteve Reyner
- Contact Person Email
- jesteve@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Investigational products
- Investigational Product Name
- BMS-986497
- Modality
- Other
- Investigational Product Name
- Azacitidine
- Active Substance
- Azacitidine
- Modality
- Small molecule
- Investigational Product Name
- Venetoclax
- Active Substance
- Venetoclax
- Modality
- Small molecule
- Combination Treatment
- Yes
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