Study of Olverembatinib (HQP1351) in Patients With CP-CML
Trial Status: active
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Inclusion Criteria
- Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age ≥ 18 years old. 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. 5. Written informed consent obtained prior to any screening procedures. 6. Patients with adequate organ functions Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.
Additional locations may be listed on ClinicalTrials.gov for NCT06423911.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not AvailableCalifornia
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableIrvine
City of Hope at Irvine Lennar
Status: Active
Contact: Paul Koller
Phone: 626-218-2405
Email: pkoller@coh.org
Long Beach
City of Hope at Long Beach Elm
Status: Active
Contact: Paul Koller
Phone: 626-218-2405
Email: pkoller@coh.org
Upland
Georgia
Newnan
City of Hope Atlanta Cancer Center
Status: Active
Contact: Paul Koller
Phone: 626-218-2405
Email: pkoller@coh.org
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableKentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Lamis Farah
Phone: 410-328-0915
Email: lamis.farah@umm.edu
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not AvailableNorth Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not AvailableThe hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate
compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B,
olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I
mutation.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationAscentage Pharma
- Primary IDHQP1351CG301
- Secondary IDsNCI-2024-05612
- ClinicalTrials.gov IDNCT06423911