To hear about similar clinical trials, please enter your email below
Trial Title:
Study of Olverembatinib (HQP1351) in Patients With CP-CML
NCT ID:
NCT06423911
Condition:
Chronic Myeloid Leukemia
CML
CML, Chronic Phase
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Bosutinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Part A 2:1 ratio Part B: control
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
olverembatinib
Description:
olverembatinib QOD
Arm group label:
Part A, RCT, olverembatinib arm and bosutinib arm
Arm group label:
Part B, SAT, olverembatinib arm
Intervention type:
Drug
Intervention name:
Bosutinib
Description:
Bosutnib QD
Arm group label:
Part A, RCT, olverembatinib arm and bosutinib arm
Summary:
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of
Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia
(POLARIS-2)
Detailed description:
The 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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
February 5, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Ascentage Pharma Group Inc.
Agency class:
Industry
Source:
Ascentage Pharma Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06423911
