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A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia

NCT07623200

RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Essential Thrombocythemia

Interventions: INCA033989, Best Available Treatment

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.

Other protocol-defined Inclusion/Exclusion Criteria apply.
Locations (180)
  • Gilbert, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • Greenbrae, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • San Francisco, California, United States
  • Lone Tree, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Miami, Florida, United States
  • Weston, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Westwood, Kansas, United States
  • Baltimore, Maryland, United States
  • Columbia, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Columbia, Missouri, United States
  • St Louis, Missouri, United States
  • Hackensack, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • + 150 more on CT.gov