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Phase II Study of Olverembatinib for Newly Diagnosed CML

This study is testing a drug called olverembatinib to see how well it works and if it's safe for people newly diagnosed with chronic myeloid leukemia (CML) in the chronic phase. CML is a type of cancer that affects the blood and bone marrow. You might be able to join if you are an adult (18 or older) with CML that is Ph-positive or BCR::ABL1 positive. You may also be eligible if you've had limited prior treatment with certain medications. The study will look at how many people achieve a major molecular response (MMR) and complete cytogenetic response (CCyR) after 12 months, and will also track side effects. This study aims to enroll 50 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year. Other outcomes will be assessed at various time points up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06817720

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:olverembatinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs
Measured over Through study completion; an average of 1 year

Conditions

Chronic Myeloid Leukemia

Explore related trials

Chronic Myeloid Leukemia, BCR-ABL1 Positivet(9;22)(q34.1;q11.2)

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Fadi Haddad, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Fadi Haddad, MD
[email protected]
346-234-4135
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Safety and adverse events (AEsThrough 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