Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Phase 2

Not yet recruiting

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: olverembatinib

• Registration Number: NCT06817720
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.

Detailed Description

Primary Objectives

* To assess the rate of MMR by 12 months. Secondary Objectives

* To assess the rate of CCyR by 12 months.

* To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6, 12, 18, 24, and 36 months of therapy.

* To estimate the rate of sustained deep molecular response.

* To estimate event-free survival and overall survival.

* To assess the toxicity of olverembatinib monotherapy.

* To assess health-related quality of life (HRQOL) of the participants.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-07-30
• Primary Completion: 2025-07-30
• Study Completion: 2027-03-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.

• Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.

• Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.

• Participants who are receiving any other investigational agents.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to olverembatinib or other agents used in study.

• NYHA cardiac class 3-4 heart disease

• Cardiac Symptoms: Participants meeting the following criteria are not eligible unless cleared by cardiologist

  • Uncontrolled angina within 3 months
  • Diagnosed or suspected congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
  • Prolonged QTc interval on pre-entry electrocardiogram (> 460 msec)

• History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist:

  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

    • Participants with active, uncontrolled psychiatric disorders including psychosis, major depression, and bipolar disorders.
    • Participants with cognitive impairment or psychiatric illness/social situations that would limit compliance with study requirements.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
    • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

  • Uncontrolled and/or active systemic infection (viral, bacterial or fungal)

  • Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment and having detectable virus load. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface antigen negative, anti-HBs antibody positive and antihepatitis B core antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins may participate.

    • Pregnant women are excluded from this study because olverembatinib is a BCR::ABL1 TKI with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with olverembatinib, breastfeeding should be discontinued if the mother is treated with olverembatinib. These potential risks may also apply to other agents used in this study.
    • Participants in late chronic phase (i.e., time from diagnosis to treatment > 12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:

  • Early chronic phase: time from diagnosis to therapy ≤ 12 months.

  • Late chronic phase: time from diagnosis to therapy > 12 months.

  • Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow.

  • Accelerated phase CML: presence of any of the following features:

    i. Peripheral or marrow blasts 15% or more. ii. Peripheral or marrow basophils 20% or more. iii. Thrombocytopenia < 100 x 109/L unrelated to therapy. iv. Documented extramedullary blastic disease outside liver or spleen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Olveremebatinib	olverembatinib	Patients will receive single agent olverembatinib at a dose of 30 mg orally every other day (QOD)

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States