Study of Olverembatinib (HQP1351) in Patients With CML-CP (POLARIS-2)

September 10, 2026 updated by: Ascentage Pharma Group Inc.

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).

Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • Ascentage Investigative Site #2107
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Ascentage Investigative Site #2105
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Ascentage Investigative Site #2115
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Ascentage Investigative Site #2106
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Ascentage Investigative Site #5211
      • Gilly, Belgium, 6060
        • Recruiting
        • Ascentage Investigative Site #5212
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Ascentage Investigative Site #5208
      • Roeselare, Belgium, 8800
        • Recruiting
        • Ascentage Investigative Site #5209
      • Yvoir, Belgium, 5530
        • Recruiting
        • Ascentage Investigative Site #5210
  • Canada
      • Toronto, Canada, M5G 2M9
        • Recruiting
        • Ascentage Investigative Site #8004
  • France
      • Amiens, France, 80054
        • Recruiting
        • Ascentage Investigative Site #5037
      • Bobigny, France, 93000
        • Recruiting
        • Ascentage Investigative Site #5015
      • Nice, France, 06202
        • Recruiting
        • Ascentage Investigative Site #5017
      • Rouen, France, 76038
        • Recruiting
        • Ascentage Investigative Site #5016
      • Toulouse, France, 31059
        • Recruiting
        • Ascentage Investigative Site #5023
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Ascentage Investigative Site #5708
      • Dresden, Germany, 01307
        • Recruiting
        • Ascentage Investigative Site #5709
  • India
      • Bangalore, India, 560027
        • Active, not recruiting
        • Ascentage Investigative Site #9118
      • Haryāna, India, 122002
        • Active, not recruiting
        • Ascentage Investigative Site #9120
      • Haryāna, India, 124105
        • Active, not recruiting
        • Ascentage Investigative Site #9102
      • Hyderabad, India, 500033
        • Active, not recruiting
        • Ascentage Investigative Site #9110
      • Kolkata, India, 700014
        • Active, not recruiting
        • Ascentage Investigative Site #9116
      • Kolkata, India, 700054
        • Active, not recruiting
        • Ascentage Investigative Site #9115
      • New Delhi, India, 110029
        • Active, not recruiting
        • Ascentage Investigative Site #9101
      • New Delhi, India, 110076
        • Active, not recruiting
        • Ascentage Investigative Site #9103
      • Pune, India, 411001
        • Active, not recruiting
        • Ascentage Investigative Site #9119
      • Thiruvananthapuram, India, 695011
        • Active, not recruiting
        • Ascentage Investigative Site #9113
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Ascentage Investigative Site #5535
      • Candiolo, Italy, 10060
        • Recruiting
        • Ascentage Investigative Site #5534
      • Catania, Italy, 95123
        • Recruiting
        • Ascentage Investigative Site #5527
      • Lecce, Italy, 73100
        • Recruiting
        • Ascentage Investigative Site #5523
      • Meldola, Italy, 47014
        • Recruiting
        • Ascentage Investigative Site #5529
      • Messina, Italy, 98124
        • Not yet recruiting
        • Ascentage Investigative Site #5537
      • Milan, Italy, 20122
        • Recruiting
        • Ascentage Investigative Site #5553
      • Naples, Italy, 80131
        • Recruiting
        • Ascentage Investigative Site #5530
      • Novara, Italy, 28100
        • Recruiting
        • Ascentage Investigative Site #5524
      • Padova, Italy, 35128
        • Recruiting
        • Ascentage Investigative Site #5525
      • Pisa, Italy, 56126
        • Recruiting
        • Ascentage Investigative Site #5526
      • Roma, Italy, 00144
        • Recruiting
        • Ascentage Investigative Site #5528
      • Roma, Italy, 00161
        • Recruiting
        • Ascentage Investigative Site #5522
      • Roma, Italy, 00168
        • Not yet recruiting
        • Ascentage Investigative Site #5510
      • Torino, Italy, 10126
        • Not yet recruiting
        • Ascentage Investigative Site #5552
      • Torino, Italy, 10128
        • Recruiting
        • Ascentage Investigative Site #5521
      • Varese, Italy, 21100
        • Recruiting
        • Ascentage Investigative Site #5536
  • Japan
      • Ehime, Japan, 790-8524
        • Recruiting
        • Ascentage Investigative Site #8101
      • Kyoto, Japan, 602-8566
        • Recruiting
        • Ascentage Investigative Site #8102
      • Okayama, Japan, 701-1192
        • Recruiting
        • Ascentage Investigative Site #8112
      • Osaka, Japan, 565-0871
        • Recruiting
        • Ascentage Investigative Site #8105
      • Sapporo, Japan, 003-0006
        • Recruiting
        • Ascentage Investigative Site #8106
      • Sapporo, Japan, 060-8648
        • Recruiting
        • Ascentage Investigative Site #8107
      • Tochigi, Japan, 321-0207
        • Recruiting
        • Ascentage Investigative Site #8109
      • Tokyo, Japan, 113-8677
        • Recruiting
        • Ascentage Investigative Site #8114
      • Tokyo, Japan, 130-8575
        • Recruiting
        • Ascentage Investigative Site #8117
      • Tokyo, Japan, 141-8625
        • Recruiting
        • Ascentage Investigative Site #8110
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Ascentage Investigative Site #8104
      • Yamanashi, Japan, 409-3898
        • Recruiting
        • Ascentage Investigative Site #8103
  • Poland
      • Gdansk, Poland, 80214
        • Recruiting
        • Ascentage Investigative Site #4213
      • Gdansk, Poland, 80219
        • Recruiting
        • Ascentage Investigative Site #4212
      • Katowice, Poland, 40519
        • Recruiting
        • Ascentage Investigative Site #4207
      • Krakow, Poland, 30688
        • Recruiting
        • Ascentage Investigative Site #4209
      • Lodz, Poland, 93513
        • Recruiting
        • Ascentage Investigative Site #4211
      • Torun, Poland, 87100
        • Recruiting
        • Ascentage Investigative Site #4214
      • Warsaw, Poland, 00791
        • Not yet recruiting
        • Ascentage Investigative Site #4206
      • Wałbrzych, Poland, 58309
        • Recruiting
        • Ascentage Investigative Site #4210
  • Russia
      • Moscow, Russia, 125167
        • Active, not recruiting
        • Ascentage Investigative Site #3227
      • Saint Petersburg, Russia, 191024
        • Active, not recruiting
        • Ascentage Investigative Site #3228
      • Saint Petersburg, Russia, 194291
        • Active, not recruiting
        • Ascentage Investigative Site #3213
      • Saint Petersburg, Russia, 197341
        • Active, not recruiting
        • Ascentage Investigative Site #3212
  • Singapore
      • Singapore, Singapore, 117599
        • Recruiting
        • Ascentage Investigative Site #6602
      • Singapore, Singapore, 168583
        • Recruiting
        • Ascentage Investigative Site #6601
  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Ascentage Investigative Site #8206
      • Busan, South Korea, 49241
        • Recruiting
        • Ascentage Investigative Site #8207
      • Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Ascentage Investigative Site #8204
      • Seoul, South Korea, 03080
        • Recruiting
        • Ascentage Investigative Site #8201
      • Seoul, South Korea, 05505
        • Recruiting
        • Ascentage Investigative Site #8202
      • Seoul, South Korea, 06351
        • Recruiting
        • Ascentage Investigative Site #8205
      • Seoul, South Korea, 06591
        • Recruiting
        • Ascentage Investigative Site #8203
      • Uijeongbu-si, South Korea, 11749
        • Recruiting
        • Ascentage Investigative Ste #8208
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Ascentage Investigative Site #6015
      • Barcelona, Spain, 08035
        • Recruiting
        • Ascentage Investigative Site #6020
      • Elche, Spain, 03293
        • Recruiting
        • Ascentage Investigative Site #6047
      • L'Hospitalet de Llobregat, Spain, 08906
        • Recruiting
        • Ascentage Investigative Site #6014
      • Madrid, Spain, 28006
        • Recruiting
        • Ascentage Investigative Site #6035
      • Madrid, Spain, 28007
        • Recruiting
        • Ascentage Investigative Site #6013
      • Madrid, Spain, 28031
        • Recruiting
        • Ascentage Investigative Site #6033
      • Madrid, Spain, 28041
        • Recruiting
        • Ascentage Investigative Site #6011
      • Madrid, Spain, 28046
        • Recruiting
        • Ascentage Investigative Site #6032
      • Majadahonda, Spain, 28222
        • Recruiting
        • Ascentage Investigative Site #6037
      • Murcia, Spain, 30120
        • Not yet recruiting
        • Ascentage Investigative Site #6051
      • Málaga, Spain, 29010
        • Recruiting
        • Ascentage Investigative Site #6012
      • Málaga, Spain, 29010
        • Recruiting
        • Ascentage Investigative Site #6039
      • Ourense, Spain, 32005
        • Recruiting
        • Ascentage Investigative Site #6036
      • Valencia, Spain, 46017
        • Recruiting
        • Ascentage Investigative Site #6038
      • Zaragoza, Spain, 50009
        • Recruiting
        • Ascentage Investigative Site #6041
  • Turkey (Türkiye)
      • Adapazarı, Turkey (Türkiye), 54100
        • Recruiting
        • Ascentage Investigative Site #9216
      • Ankara, Turkey (Türkiye), 06050
        • Recruiting
        • Ascentage Investigative Site #9218
      • Ankara, Turkey (Türkiye), 06170
        • Recruiting
        • Ascentage Investigative Site #9204
      • Battalgazi, Turkey (Türkiye), 44210
        • Recruiting
        • Ascentage Investigative Site #9215
      • Istanbul, Turkey (Türkiye), 34452
        • Not yet recruiting
        • Ascentage Investigative Site #9219
      • Kepez, Turkey (Türkiye), 07025
        • Recruiting
        • Ascentage Investigative Site #9205
      • Mezitli, Turkey (Türkiye), 33200
        • Recruiting
        • Ascentage Investigative Site #9208
      • Ortahisar, Turkey (Türkiye), 61080
        • Recruiting
        • Ascentage Investigative Site #9213
      • Samsun, Turkey (Türkiye), 55270
        • Recruiting
        • Ascentage Investigative Site #9214
      • Yenimahalle, Turkey (Türkiye), 06200
        • Recruiting
        • Ascentage Investigative Site #9212
      • Çankaya, Turkey (Türkiye), 06800
        • Not yet recruiting
        • Ascentage Investigative Site #9217
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Ascentage Investigative Site #7017
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • Ascentage Investigative Site #7036
      • Boston, United Kingdom, PE21 9QS
        • Recruiting
        • Ascentage Investigative Site #7021
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • Ascentage Investigative Site #7037
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Ascentage Investigative Site #7035
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Ascentage Investigative Site #7016
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Ascentage Investigative Site #7015
      • Newport, United Kingdom, NP20 2UB
        • Recruiting
        • Ascentage Investigative Site #7018
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • Ascentage Investigative Site #1044
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Ascentage Investigative Site #1112
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • Ascentage Investigative Site #1111
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Ascentage Investigative Site #1062
      • Irvine, California, United States, 92618
        • Recruiting
        • Ascentage Investigative Site #1099
      • La Jolla, California, United States, 92037
        • Recruiting
        • Ascentage Investigative Site #1075
      • Long Beach, California, United States, 90813
        • Recruiting
        • Ascentage Investigative Site #1100
      • Los Angeles, California, United States, 90024
        • Recruiting
        • Ascentage Investigative Site #1059
      • Sacramento, California, United States, 95817
        • Recruiting
        • Ascentage Investigative Site #1121
      • Upland, California, United States, 91786
        • Recruiting
        • Ascentage Investigative Site #1109
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Ascentage Investigative Site #1045
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Ascentage Investigative Site #1110
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Ascentage Investigative Site #1055
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Ascentage Investigative Site #1095
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Ascentage Investigative Site #1069
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascentage Investigative Site #1065
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • Ascentage Investigative Site #1084
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Ascentage Investigative Site #1058
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Ascentage Investigative Site #1801
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Ascentage Investigative Site #1056
      • Detroit, Michigan, United States, 49254
        • Recruiting
        • Ascentage Investigative Site #1023
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Ascentage Investigative Site #1088
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Not yet recruiting
        • Ascentage Investigative Site #1097
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Ascentage Investigative Site #1066
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Ascentage Investigative Site #1113
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Ascentage Investigative Site #1064
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Ascentage Investigative Site #1054
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Ascentage Investigative Site #1098
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Ascentage Investigative Site #1072
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • Ascentage Investigative Site #1068
      • Shirley, New York, United States, 11967
        • Recruiting
        • Ascentage Investigative Site #1053
      • Stony Brook, New York, United States, 11794
        • Not yet recruiting
        • Ascentage Investigative Site #1160
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Not yet recruiting
        • Ascentage Investigative Site #1019
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Ascentage Investigative Site #1043
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Not yet recruiting
        • Ascentage Investigative Site #1173
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Ascentage Investigative Site #1096
      • Mayfield Heights, Ohio, United States, 44124
        • Not yet recruiting
        • Ascentage Investigative Site #1174
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Ascentage Investigative Site #1139
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Ascentage Investigative Site #1057
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Ascentage Investigative Site #1022
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Ascentage Investigative Site #1063
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Ascentage Investigative Site #1089
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Ascentage Investigative Site #1051
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascentage Investigative Site #1036
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ascentage Investigative Site #1501
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Recruiting
        • Ascentage Investigative Site #1050
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Ascentage Investigative Site #1136
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Ascentage Investigative Site #1135
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Ascentage Investigative Site #1806
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Ascentage Investigative Site #1510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  5. Patient has adequate organ function

Exclusion Criteria

Patients eligible for this study must not meet any of the following criteria:

  1. For Part A only: T315I or V299L 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Part A, RCT, olverembatinib arm and bosutinib arm
Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs
Drug: olverembatinib
olverembatinib QOD
Drug: Bosutinib
Bosutnib QD
Other: Part B, SAT, olverembatinib arm
To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
Drug: olverembatinib
olverembatinib QOD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-Week MMR Rate (Part A)
Time Frame: 24 weeks
To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib
24 weeks
24-Week MMR Rate (Part B)
Time Frame: 24 weeks
To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
96-Week MMR Rate (Part A)
Time Frame: 96 weeks
To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib
96 weeks
96-Week MMR Rate (Part B)
Time Frame: 96 weeks
To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation
96 weeks
Cytogenic Response Rate (Part A)
Time Frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.
Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Cytogenic Response Rate (Part B)
Time Frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation
Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Progression Free Survival (PFS) (Part A)
Time Frame: 5 years after the last patient received the first study dose
To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib
5 years after the last patient received the first study dose
Progression Free Survival (PFS) (Part B)
Time Frame: 5 years after the last patient received the first study dose
To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation
5 years after the last patient received the first study dose
Overall Survival (OS) (Part A)
Time Frame: 5 years after the last patient received the first study dose
To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib
5 years after the last patient received the first study dose
Overall Survival (OS) (Part B)
Time Frame: 5 years after the last patient received the first study dose
To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation
5 years after the last patient received the first study dose
Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)
Time Frame: 96 weeks after the last patient received the first study dose
According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.
96 weeks after the last patient received the first study dose
Characterization of population pharmacokinetics of olverembatinib (Parts A and B)
Time Frame: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)
Blood samples will be collected to measure the plasma concentration of olverembatinib
At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascentage Pharma Group Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elias Jabbour, M.D., M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HQP1351CG301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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