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OpenTrials
Enrolling by Invitation

NCT Number: NCT07383298

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. 12-month CCyR or BCR::ABL1 ≤1% rate

    Time frame: 12 month

    12-month CCyR or BCR::ABL1 ≤1% rate

Secondary outcomes

  1. Cumulative MMR rate

    Time frame: 24 months

    Cumulative MMR rate

  2. Cumulative MR4 rate

    Time frame: 24 months

    Cumulative MR4 rate

  3. Cardiovascular and cerebrovascular events

    Time frame: 24 month

    Cardiovascular and cerebrovascular events

  4. Quality of life by EORTC QLQ-C30

    Time frame: 24 months

    Quality of life by EORTC QLQ-C30

Sponsors and collaborators

Lead sponsor

Qian Jiang

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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