Clinical trial • Phase I • Oncology
ABD-3001 for Acute myeloid leukemia (relapsed/refractory) | Myelodysplastic syndrome (high/very-high risk)
Phase I trial of ABD-3001 for Acute myeloid leukemia (relapsed/refractory) | Myelodysplastic syndrome (high/very-high risk). 61 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukemia (relapsed/refractory) | Myelodysplastic syndrome (high/very-high risk)
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 12-11-2024
Trial design
Phase I trial across 5 sites in France.
- Target Sample Size
- 61
Recruitment
- Planned Sample Size
- 61
- Recruitment Window Months
- 66
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 61
France
- Earliest CTIS Part Ii Submission Date
- 10-10-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 524
- Number Of Sites
- 5
- Number Of Participants
- 61
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Mael HEIBLIG
- Principal Investigator Email
- mael.heiblig@chu-lyon.fr
- Contact Person Name
- Mael HEIBLIG
- Contact Person Email
- mael.heiblig@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- CEPCM
- Principal Investigator Name
- Regis COSTELLO
- Principal Investigator Email
- regis.costello@ap-hm.fr
- Contact Person Name
- Regis COSTELLO
- Contact Person Email
- regis.costello@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- clinical hematology
- Principal Investigator Name
- Ludovic GABELLIER
- Principal Investigator Email
- l-gabellier@chu-montpellier.fr
- Contact Person Name
- Ludovic GABELLIER
- Contact Person Email
- l-gabellier@chu-montpellier.fr
- Site Name
- Hopital Saint Louis
- Department Name
- INSERM CIC 1427 - INSERM U944
- Principal Investigator Name
- Lina BENAJIBA
- Principal Investigator Email
- lina.benajiba@aphp.fr
- Contact Person Name
- Lina BENAJIBA
- Contact Person Email
- lina.benajiba@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Clinical hematologie
- Principal Investigator Name
- Thomas CLUZEAU
- Principal Investigator Email
- cluzeau.t@chu-nice.fr
- Contact Person Name
- Thomas CLUZEAU
- Contact Person Email
- cluzeau.t@chu-nice.fr
Sponsor
Primary sponsor
- Full Name
- Advanced Biodesign
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- ABD-3001
- First In Human
- Yes
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