Clinical trial • Phase I/II • Haematology

PentixaTher radiolabelled with Lutetium-177 for Acute leukemia

Phase I/II trial of PentixaTher radiolabelled with Lutetium-177 for Acute leukemia. 21 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Acute leukemia
Trial Stage
Phase I/II
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
21-11-2023
First CTIS Authorization Date
25-03-2024

Trial design

Phase I/II trial across 8 sites in France.

Biomarker Stratified
True, biomarker: CXCR4 (CXCR4+ patients)
Target Sample Size
21
Trial Duration For Participant
1096

Recruitment

Planned Sample Size
21
Recruitment Window Months
36

Geography

Total Number Of Sites
8
Total Number Of Participants
21

France

Earliest CTIS Part Ii Submission Date
08-01-2024
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
710
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hématologie
Principal Investigator Name
Mathilde HUNAULT
Principal Investigator Email
mahunault@chu-angers.fr
Contact Person Name
Mathilde HUNAULT
Contact Person Email
mahunault@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Médecine Nucleaire
Principal Investigator Name
Françoise KRAEBER-BODERE
Principal Investigator Email
francoise.bodere@chu-nantes.fr
Contact Person Name
Françoise KRAEBER-BODERE
Contact Person Email
francoise.bodere@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie
Principal Investigator Name
Patrice CHEVALLIER
Principal Investigator Email
patrice.chevallier@chu-nantes.fr
Contact Person Name
Patrice CHEVALLIER
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hématologie
Principal Investigator Name
Cécile MOLUCON-CHABROT
Principal Investigator Email
cchabrot@chu-clermontferrand.fr
Contact Person Name
Cécile MOLUCON-CHABROT
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Médecine Nucleaire
Principal Investigator Name
Charles MESGUICH
Principal Investigator Email
charles.mesguich@chu-bordeaux.fr
Contact Person Name
Charles MESGUICH
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie
Principal Investigator Name
Pierre-Yves DUMAS
Principal Investigator Email
pierre-yves.dumas@chu-bordeaux.fr
Contact Person Name
Pierre-Yves DUMAS
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Médecine Nucleaire
Principal Investigator Name
Clément BOURON
Principal Investigator Email
clement.bouron@chu-angers.fr
Contact Person Name
Clément BOURON
Contact Person Email
clement.bouron@chu-angers.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Médecine Nucleaire
Principal Investigator Name
Florent CACHIN
Principal Investigator Email
florent.cachin@clermont.unicancer.fr
Contact Person Name
Florent CACHIN

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Nantes
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
177Lu-PentixaTher
Active Substance
PentixaTher radiolabelled with Lutetium-177
Modality
Radiopharmaceutical

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