A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)
Incyte Corporation
Summary
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of high-risk ET. * Presence of mutCALR. * Prior treatment with at least 1 cytoreductive therapy. Exclusion Criteria: * Presence of any hematologic malignancy other than ET. * Major bleeding or thrombosis within the last 3 months prior to study enrollment. * Any prior allogenic or autologous stem-cell transplantation. * Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy. * Prior nonhematologic malignancy except for the following: Mali…