Tests INCA033989 Against Standard Care in Essential Thrombocythemia
Tests INCA033989 against standard treatment in adults with essential thrombocythemia and a CALR mutation.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
Key facts
- Where
- Bari, Bergamo, Bologna, Catania, Florence, Genova, Meldola, Milan, Novara, Pavia, Rome, Torino, Udine, and Verona, ItalySee the 16 sites
- Phase
- Phase 3
Where in Italy
- Aou Policlinico Consorziale Bari - Uo Ematologia Con TrapiantoBari, ItalyNot yet recruiting
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola MalBologna, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San MarcoCatania, ItalyNot yet recruiting
- Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)Florence, ItalyNot yet recruiting
- Irccs - Azienda Ospedaliera Universitaria - Ist San MartinoGenova, ItalyNot yet recruiting
- Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, EmatologiaMeldola, ItalyNot yet recruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoMilan, ItalyNot yet recruiting
- Ao Maggiore Della CaritaNovara, ItalyNot yet recruiting
- Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San MatteoPavia, ItalyNot yet recruiting
- Ospedale S. EugenioRome, ItalyNot yet recruiting
- Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino GemelliRome, ItalyNot yet recruiting
- Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di RomaRome, ItalyNot yet recruiting
- AO Ordine Mauriziano di TorinoTorino, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Santa Maria della MisericordiaUdine, ItalyNot yet recruiting
- Universita' Degli Studi Di VeronaVerona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07623200EU 2026-525398-38-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Confirmed diagnosis of high-risk ET; Presence of mutCALR; Prior treatment with at least 1 cytoreductive therapy.
Exclusion: 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; Presence of any hematologic malignancy other than ET.