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DasaHIT: Dasatinib Holiday Schedule in CML
NCT02890784Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2016
- Primary completion
- Mar 2023
- Countries
- 1
- Sponsor
- Friedrich Schiller University Jena
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- dasatinib
- Conditions
- chronic myeloid leukemia (CML)
01
Overview
Phase 3, randomised, open-label trial of dasatinib in chronic myeloid leukemia (CML) (2 arms), sponsored by Friedrich Schiller University Jena. Primary endpoints: Cumulative Toxicity Score at 24 months and Rate of Molecular Response at 24 months. Started Aug 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard Arm
Dasatinib 100mg daily (7x100mg)
Study Arm
Dasatinib 100mg weekdays only (5x100mg + 2 days off)
03
Who it enrols
Adult patients with Ph+ CP-CML, either newly diagnosed (1st line) or with resistance/intolerance to prior TKIs (>=2nd line). Excludes prior AlloSCT, significant cardiac disease, and active autoimmune disorders.
04
Endpoints
Primary
Cumulative Toxicity Score
Rate of Molecular Response
Secondary
Quality of Life Assessment
Rate of Molecular Response
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