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

NCT06817720 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1637NCI-2025-00934
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Olveremebatinib

EXPERIMENTAL

Patients will receive single agent olverembatinib at a dose of 30 mg orally every other day (QOD)

Drug: olverembatinib

Interventions

olverembatinib DRUG

GIven by PO

Treatment with Olveremebatinib

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

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

• Fadi Haddad, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadi Haddad, MD

CONTACT

346-234-4135; fhaddad@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): March 7, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)