Clinical trial • Phase III • Immunology|Oncology

Cladribine for Acute leukemia|Myelodysplastic syndrome

Phase III trial of Cladribine for Acute leukemia|Myelodysplastic syndrome. 29 participants.

Overview

Trial Therapeutic Area
Immunology|Oncology
Trial Disease
Acute leukemia|Myelodysplastic syndrome
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-08-2024
First CTIS Authorization Date
07-10-2024

Trial design

Phase III trial across 1 site in France.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
29

Eligibility

Recruits 29 No vulnerable populations selected (isVulnerablePopulationSelected: false).

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false)

Recruitment

Planned Sample Size
29
Recruitment Window Months
96

Geography

Total Number Of Sites
1
Total Number Of Participants
29

France

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
35
Number Of Sites
1
Number Of Participants
29

Sites

Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Principal Investigator Name
Raynier DEVILLIER
Principal Investigator Email
devillierr@ipc.unicancer.fr
Contact Person Name
Raynier DEVILLIER
Contact Person Email
devillierr@ipc.unicancer.fr
Number Of Participants
29

Sponsor

Primary sponsor

Full Name
Institut Paoli Calmettes
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Cladribine
Active Substance
Cladribine
Modality
Small molecule

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