Not currently recruiting at University of California Health

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

a study on Essential Thrombocythemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around

Description

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.

Official Title

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)

Keywords

Essential Thrombocythemia, calreticulin (CALR), mutCALR, peginterferon alfa-2a, INCA033989, Best Available Treatment, Best Available Therapy (BAT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Confirmed diagnosis of high-risk ET.
  • Presence of mutCALR.
  • Prior treatment with at least 1 cytoreductive therapy.

You CAN'T join if...

  • 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

  • University of California, Los Angeles Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCSF withdrawn
    San Francisco California 94143 United States
  • Marin Cancer Care accepting new patients
    Greenbrae California 94904 United States
  • Stanford Cancer Center not yet accepting patients
    Palo Alto California 94304 United States
  • City of Hope Medical Center not yet accepting patients
    Duarte California 91010 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia (EXCALIBUR-ET2)
ID
NCT07623200
Phase
Phase 3 Essential Thrombocythemia Research Study
Study Type
Interventional
Participants
Expecting 426 study participants
Last Updated