Chronic Myeloid LeukemiaNCT07383298
Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase
An observational study of Chronic Myeloid Leukemia, run by Qian Jiang at 1 site in China.
Trial summary
This study is a multicenter observational study aimed to investigate the efficacy and safety of olverembatinib dose reduction to 20 mg every other day (QOD) in patients with chronic myeloid leukemia (CML) in chronic phase or accelerated phase who have achieved complete cytogenetic response (CCyR) or BCR::ABL1 (IS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Olverembatinib 20mg
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic myeloid leukemia in chronic phase or accelerated phase received olverembatinib
Who may be able to join
- Age ≥ 18 years.
- Diagnosed with chronic myeloid leukemia in the chronic phase, currently receiving olverembatinib 30 mg or 40 mg every other day (QOD). The patient must have achieved and maintained at least two consecutive confirmations of complete cytogenetic response (CCyR) or BCR::ABL1 (IS) ≤ 1% prior to enrollment and has decided to switch to olverembatinib 20 mg QOD.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2.
- Signed informed consent must be obtained prior to any study-specific procedures. If the patient is unable to sign due to their medical condition, informed consent may be provided by the legal guardian or an immediate family member.
- Subjects must be willing and able to comply with all study procedures and the follow-up schedule.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Female patients with a positive serum β-HCG test, or who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Uncontrolled infection at the time of enrollment; or severe complications requiring mechanical ventilatory support or presenting with hemodynamic instability; ③ Inability or unwillingness to provide signed informed consent; ④ Any condition or disease that, in the judgment of the investigator, may compromise subject safety or interfere with the evaluation of the efficacy or safety of the investigational drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
This study is a multicenter observational study aimed to investigate the efficacy and safety of olverembatinib dose reduction to 20 mg every other day (QOD) in patients with chronic myeloid leukemia (CML) in chronic phase or accelerated phase who have achieved complete cytogenetic response (CCyR) or BCR::ABL1 (IS) ≤1%. Approximately 100 cases are planned to be enrolled.Primary endpoint: Maintenance rate of CCyR or BCR::ABL1 (IS) ≤1% within 12 months.
Secondary endpoints: Cumulative major molecular response (MMR) rate, cumulative MR4 rate, cumulative MR4.5 rate, MMR loss-free survival rate, MR4 loss-free survival rate, treatment failure-free survival rate, progression-free survival rate, overall survival rate, and safety.
Data analysis will be performed using SAS version 9.4 and R version 4.1.2. The loss-free survival rates will be calculated using the Log-rank and Kaplan-Meier methods. The cumulative response achievement rates will be calculated using the Fine-Gray method. Multivariate analysis will employ COX regression to identify relevant risk factors significantly affecting time-to-event variables, with hazard ratios (HR) and confidence intervals calculated. All adverse events occurring in subjects during the clinical trial period will be observed, including abnormal clinical symptoms, vital signs, and laboratory findings, with documentation of their clinical manifestation characteristics, severity, onset time, duration, management, and prognosis, and assessment of their relationship with the study drug. The plan is to enroll 100 cases within 12-24 months, with at least 12 months of observation.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Olverembatinib 20mg
- Keywords
- Chronic myeloid leukemia, Olverembatinib, Dose Optimization
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olverembatinib 20mgDrug
Olverembatinib dose reduction to 20 mg every other day after achieving CCyR or BCR::ABL1 (IS) ≤1% in patients with chronic myeloid leukemia in chronic phase or accelerated phase.
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month CCyR or BCR::ABL1 ≤1% rate
12-month CCyR or BCR::ABL1 ≤1% rate
Measured: 12 month
Secondary outcomes (4)
Cumulative MMR rate
Cumulative MMR rate
Measured: 24 months
Cumulative MR4 rate
Cumulative MR4 rate
Measured: 24 months
Cardiovascular and cerebrovascular events
Cardiovascular and cerebrovascular events
Measured: 24 month
Quality of life by EORTC QLQ-C30
Quality of life by EORTC QLQ-C30
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start16 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qian Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qian Jiang, Peking University People's Hospital
- Investigators
- Qian Jiang, Dr., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383298
- Sponsor's protocol ID
- 2025PHB563-001
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase
- ClinicalTrials.gov ID
- NCT07383298
- Acronym / sponsor ID
- 2025PHB563-001
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia, Olverembatinib, Dose Optimization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qian JiangUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter observational study aimed to investigate the efficacy and safety of olverembatinib dose reduction to 20 mg every other day (QOD) in patients with chronic myeloid leukemia (CML) in chronic phase or accelerated phase who have achieved complete cytogenetic response (CCyR) or BCR::ABL1 (IS) ≤1%. Approximately 100 cases are planned to be enrolled.Primary endpoint: Maintenance rate of CCyR or BCR::ABL1 (IS) ≤1% within 12 months.
Secondary endpoints: Cumulative major molecular response (MMR) rate, cumulative MR4 rate, cumulative MR4.5 rate, MMR loss-free survival rate, MR4 loss-free survival rate, treatment failure-free survival rate, progression-free survival rate, overall survival rate, and safety.
Data analysis will be performed using SAS version 9.4 and R version 4.1.2. The loss-free survival rates will be calculated using the Log-rank and Kaplan-Meier methods. The cumulative response achievement rates will be calculated using the Fine-Gray method. Multivariate analysis will employ COX regression to identify relevant risk factors significantly affecting time-to-event variables, with hazard ratios (HR) and confidence intervals calculated. All adverse events occurring in subjects during the clinical trial period will be observed, including abnormal clinical symptoms, vital signs, and laboratory findings, with documentation of their clinical manifestation characteristics, severity, onset time, duration, management, and prognosis, and assessment of their relationship with the study drug. The plan is to enroll 100 cases within 12-24 months, with at least 12 months of observation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic myeloid leukemia in chronic phase or accelerated phase received olverembatinib
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosed with chronic myeloid leukemia in the chronic phase, currently receiving olverembatinib 30 mg or 40 mg every other day (QOD). The patient must have achieved and maintained at least two consecutive confirmations of complete cytogenetic response (CCyR) or BCR::ABL1 (IS) ≤ 1% prior to enrollment and has decided to switch to olverembatinib 20 mg QOD.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2.
- Signed informed consent must be obtained prior to any study-specific procedures. If the patient is unable to sign due to their medical condition, informed consent may be provided by the legal guardian or an immediate family member.
- Subjects must be willing and able to comply with all study procedures and the follow-up schedule.
Key exclusion criteria (3 listed)
- Female patients with a positive serum β-HCG test, or who are pregnant, breastfeeding, or planning to become pregnant during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olverembatinib 20mgOlverembatinib dose reduction to 20 mg every other day after achieving CCyR or BCR::ABL1 (IS) ≤1% in patients with chronic myeloid leukemia in chronic phase or accelerated phase. | Drug | – |
Primary outcome
12-month CCyR or BCR::ABL1 ≤1% rate
Time frame: 12 month
12-month CCyR or BCR::ABL1 ≤1% rate
4 secondary outcomes
Cumulative MMR rate
Time frame: 24 months
Cumulative MR4 rate
Time frame: 24 months
Cardiovascular and cerebrovascular events
Time frame: 24 month
Quality of life by EORTC QLQ-C30
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qian Jiang, Dr. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Qian Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month CCyR or BCR::ABL1 ≤1% rate (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.