A Phase 3 Test of INCA033989 vs Best Available Therapy for Essential Thrombocythemia with CALR Mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional phase 3 trial compares INCA033989 to the best available therapy in adults with high-risk essential thrombocythemia and a CALR mutation who have previously received cytoreductive treatment. Key eligibility includes confirmed high-risk ET with mutCALR and prior cytoreductive therapy, while major recent bleeding or thrombosis, certain stem cell transplants, and specific unresolved toxicities are exclusion criteria. The study is sponsored by Incyte Corporation and involves multiple sites, including centers in Alabama, Arizona, and California. The primary goal is to determine if INCA033989 improves disease control or clinical outcomes compared with current standard options. Additional protocol criteria will further refine who can participate.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Marin Cancer Care
  Greenbrae, California, United States Recruiting
• Texas Oncology-Tyler
  Tyler, Texas, United States Recruiting
• Blacktown Cancer & Haematology Centre-Blacktown Hospital
  Blacktown, New South Wales, Australia Recruiting
• Box Hill Hospital
  Melbourne, Victoria, Australia Recruiting
• University of Alabama At Birmingham Comprehensive Cancer Center
  Birmingham, Alabama, United States Not yet recruiting

+142 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.