Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase

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 Overview

• Status: Enrolling by invitation
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Drug: Olverembatinib 20mg

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic myeloid leukemia in chronic phase or accelerated phase received olverembatinib

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. 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.
3. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2.
4. 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.
5. Subjects must be willing and able to comply with all study procedures and the follow-up schedule.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month CCyR or BCR::ABL1 ≤1% rate	12-month CCyR or BCR::ABL1 ≤1% rate	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative MMR rate	Cumulative MMR rate	24 months
Cumulative MR4 rate	Cumulative MR4 rate	24 months
Cardiovascular and cerebrovascular events	Cardiovascular and cerebrovascular events	24 month
Quality of life by EORTC QLQ-C30	Quality of life by EORTC QLQ-C30	24 months

Collaborators and Investigators

• Sponsor: Qian Jiang
• Investigators: Principal Investigator: Qian Jiang, Dr., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Chronic myeloid leukemia; Olverembatinib; Dose Optimization
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; olverembatinib
• Other Study ID Numbers: 2025PHB563-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available for sharing.
• IPD Sharing Time Frame: Upon article publication

IPD Sharing Access Criteria

Access to the individual participant data (IPD) and supporting information will be granted to:

Qualified researchers, including academic and clinical investigators Individuals or teams affiliated with recognized research, healthcare, or regulatory institutions Requestors who provide a valid, scientifically sound research proposal aligned with ethical guidelines and approved by an independent review committee (e.g., an institutional review board or ethics committee) Requestors who commit to using the data only for the approved research purpose and agree to applicable terms of data use

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No