Clinical trial • Phase I|Phase III • Haematology
trametinib for Acute lymphoblastic leukemia (relapsed or refractory) | Acute myeloid leukemia (relapsed or refractory)
Phase I|Phase III trial of trametinib for Acute lymphoblastic leukemia (relapsed or refractory) | Acute myeloid leukemia (relapsed or refractory).
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Acute lymphoblastic leukemia (relapsed or refractory) | Acute myeloid leukemia (relapsed or refractory)
- Trial Stage
- Phase I|Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-10-2024
- First CTIS Authorization Date
- 16-12-2024
Trial design
Phase I|Phase III trial across 5 sites in Poland.
- Target Sample Size
- 54
Eligibility
Recruits 54 Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent in provided documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent in provided documents.
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 75
- Consent Approach
- Not specified in provided documents.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 54
Poland
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 415
- Number Of Sites
- 5
- Number Of Participants
- 54
Sites
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Instytut Hematologii i Transfuzjologii
- Contact Person Name
- Ewa Lech-Marańda
- Contact Person Email
- sekihit@ihit.waw.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Im.Adrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
- Department Name
- Klinika Hematologii i Transplantacji Szpiku
- Contact Person Name
- Grzegorz Helbig
- Contact Person Email
- ohits@spskm.katowice.pl
- Site Name
- Uniwersytet Medyczny w Poznaniu
- Department Name
- Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego
- Contact Person Name
- Lidia Gil
- Contact Person Email
- lidia.gil@skpp.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Contact Person Name
- Krzysztof Baran
- Contact Person Email
- kbaran@uck.gda.pl
- Site Name
- Uniwersytet Medyczny we Wrocławiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Contact Person Name
- Anna Czyż
- Contact Person Email
- a.czyz@umw.edu.pl
Sponsor
Primary sponsor
- Full Name
- Instytut Hematologii I Transfuzjologii
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- trametinib
- Active Substance
- trametinib
- Modality
- Small molecule
- Investigational Product Name
- gilteritinib
- Active Substance
- gilteritinib
- Modality
- Small molecule
- Combination Treatment
- Yes
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