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

Recruiting now · Phase 2

Conditions studied: Chronic Myeloid Leukemia

In brief

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

Key facts

Study ID: NCT06817720
Run by: M.D. Anderson Cancer Center
People needed: 50
Starts: 2025-10-13
Expected to finish: 2027-03-07
Last updated by the study team: 2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.

Where it is running

MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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