A Phase 3 interventional study of olverembatinib and Bosutinib in Chronic Myeloid Leukemia, CML and CML, Chronic Phase, sponsored by Ascentage Pharma Group Inc.. Recruiting at 163 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Ascentage Pharma Group Inc. (part of Ascentage Pharma Group International) · Phase 3, Interventional, and Treatment
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.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 333 is above the median of 44 across 681 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Ascentage Pharma Group Inc. is the lead sponsor of 53 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients eligible for inclusion in this study must meet all of the following criteria:
Exclusion Criteria
Patients eligible for this study must not meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Bosutinib
To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
Drug: olverembatinib
olverembatinib QOD
Bosutnib QD
24-Week MMR Rate (Part A)
To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib
Time frame: 24 weeks
24-Week MMR Rate (Part B)
To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation
Time frame: 24 weeks
96-Week MMR Rate (Part A)
To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib
Time frame: 96 weeks
96-Week MMR Rate (Part B)
To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation
Time frame: 96 weeks
Cytogenic Response Rate (Part A)
To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.
Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Cytogenic Response Rate (Part B)
To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation
Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)
Progression Free Survival (PFS) (Part A)
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
Time frame: 5 years after the last patient received the first study dose
Progression Free Survival (PFS) (Part B)
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
Time frame: 5 years after the last patient received the first study dose
Overall Survival (OS) (Part A)
To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib
Time frame: 5 years after the last patient received the first study dose
Overall Survival (OS) (Part B)
To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation
Time frame: 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)
According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.
Time frame: 96 weeks after the last patient received the first study dose
Characterization of population pharmacokinetics of olverembatinib (Parts A and B)
Blood samples will be collected to measure the plasma concentration of olverembatinib
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)
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Showing the first 100 of 163 sites across 16 countries. Choose a country and city above to see the rest.
Started Feb 2024 (actual). Primary completion is estimated for Jun 2027, 40 months after the start.
Of 24 phase 3 interventional studies under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 79. This study's planned 40 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive →