Clinical Trials in Japan / NCT07623200
Recruiting
Phase 3
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
NCT07623200 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Essential Thrombocythemia
Investigational drug(s) / intervention(s)
INCA033989 →Best Available Treatment
INCA033989: Administered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Treatment: Best Available Therapy (BAT) will be selected by the investigator.
Study 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
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.
Primary outcome measure(s)
- Durable clinicohematologic response (DCR) — Week 24
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Trial sites (175)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner Md Anderson Cancer Center | Gilbert | Arizona | Not Yet Recruiting |
| City of Hope Medical Center | Duarte | California | Not Yet Recruiting |
| Marin Cancer Care | Greenbrae | California | Recruiting |
| University of California, Los Angeles Medical Center | Los Angeles | California | Not Yet Recruiting |
| Stanford Cancer Center | Palo Alto | California | Not Yet Recruiting |
| Rocky Mountain Cancer Centers-Lone Tree | Lone Tree | Colorado | Not Yet Recruiting |
| Medstar Georgetown Medical Center, Inc | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Florida Cancer Specialists & Research Institute | Fort Myers | Florida | Not Yet Recruiting |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | Not Yet Recruiting |
| Cleveland Clinic | Weston | Florida | Not Yet Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | Not Yet Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | Not Yet Recruiting |
| University of Chicago | Chicago | Illinois | Not Yet Recruiting |
| The University of Kansas Cancer Center | Westwood | Kansas | Not Yet Recruiting |
| Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | Not Yet Recruiting |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| Beth Israel Deaconess Medical Center (Bidmc) | Boston | Massachusetts | Not Yet Recruiting |
| University of Massachusetts Medical School | Worcester | Massachusetts | Not Yet Recruiting |
| University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic | Ann Arbor | Michigan | Not Yet Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | Not Yet Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Not Yet Recruiting |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | Not Yet Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Not Yet Recruiting |
| Icahn School of Medicine At Mount Sinai | New York | New York | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| Weill Cornell Medical College - Newyork-Presbyterian Hospita | New York | New York | Not Yet Recruiting |
| Strong Memorial Hospital University of Rochester Medical Center | Rochester | New York | Not Yet Recruiting |
| Duke University Medical Center | Durham | North Carolina | Not Yet Recruiting |
| Cleveland Clinic Taussig Cancer Ctr | Cleveland | Ohio | Not Yet Recruiting |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | Not Yet Recruiting |
| Oregon Health and Science University | Portland | Oregon | Not Yet Recruiting |
| Thomas Jefferson University Sidney Kimmel Medical College | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Not Yet Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Not Yet Recruiting |
| The University of Texas-Md Anderson Cancer Center | Houston | Texas | Not Yet Recruiting |
| Ut Health Science Center At San Antonio | San Antonio | Texas | Not Yet Recruiting |
| Texas Oncology-Tyler | Tyler | Texas | Not Yet Recruiting |
| Huntsman Cancer Institute At University of Utah | Salt Lake City | Utah | Not Yet Recruiting |
| University of Washington - Fred Hutch Cancer Center | Seattle | Washington | Not Yet Recruiting |
+ 135 more sites — see the full list on the official registry below.
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Other trials for the same condition
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Active, not recruiting
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07623200 on ClinicalTrials.gov ↗ ← All trials in Japan