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

NCT07383298 | Enrolling By Invitation

• 1 other identifier: 2025PHB563-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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) ≤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

Keywords

Chronic myeloid leukemia; Olverembatinib; Dose Optimization

Outcome Measures

Primary Outcomes (1)

• 12-month CCyR or BCR::ABL1 ≤1% rate

  12-month CCyR or BCR::ABL1 ≤1% rate

  12 month

Secondary Outcomes (4)

• Cumulative MMR rate

  24 months

• Cumulative MR4 rate

  24 months

• Cardiovascular and cerebrovascular events

  24 month

• Quality of life by EORTC QLQ-C30

  24 months

Interventions

Olverembatinib 20mg DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qian Jiang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qian Jiang, Dr.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Deputy Chair, Department of Hematology

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon article publication
• 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

Locations

CN (1)