Treatment of Chronic Myeloid Leukemia with Olverembatinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of olverembatinib (HQP1351) in patients with chronic phase chronic myeloid leukemia (CP-CML). It is a global, multicenter, open-label, randomized Phase 3 study that compares olverembatinib to bosutinib in two parts: one for patients without the T315I mutation and another for those with the mutation. The study aims to determine if olverembatinib can achieve a higher major molecular response (MMR) rate and provide therapeutic benefits for both patient groups. Participants will be monitored for safety and efficacy throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria

Patients eligible for inclusion in this study must meet all of the following criteria:

1. Age ≥ 18 years old
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
5. Patient has adequate organ function

Exclusion Criteria

Patients eligible for this study must not meet any of the following criteria:

1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
6. Pregnant or nursing (lactating) women

Where it's running

• Ascentage Investigative Site #1044
  Birmingham, Alabama, United States Recruiting
• Ascentage Investigative Site #1112
  Anchorage, Alaska, United States Recruiting
• Ascentage Investigative Site #1111
  Goodyear, Arizona, United States Recruiting
• Ascentage Investigative Site #1062
  Duarte, California, United States Recruiting
• Ascentage Investigative Site #1099
  Irvine, California, United States Recruiting
• Ascentage Investigative Site #1075
  La Jolla, California, United States Recruiting

+113 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Elias Jabbour, M.D. — M.D. Anderson Cancer Center
• Study coordinator: Ascentage Clinical Operations
• Email: clinical-trials@ascentage.com
• Phone: 301-291-5658

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Olverembatinib monotherapy for adults with newly diagnosed chronic-phase CML

  We are testing whether olverembatinib can control disease and produce deep molecular responses in adults newly diagnosed with chronic-phase CML.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06817720

• Potential of asciminib in early chronic‑phase CML

  This trial will see if asciminib alone, or asciminib plus nilotinib, helps adults newly diagnosed with chronic‑phase, BCR‑ABL–positive CML reach deep molecular responses and remain off treatment.

  Recruiting at 11 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Barcelona and 10 other locations · NCT06409936

• Evaluating ELVN-001 for treating Chronic Myeloid Leukemia

  This study is testing a new treatment called ELVN-001 for people with chronic myeloid leukemia who haven't responded well to current therapies, to see if it can help them better.

  Recruiting at 38 sites Phase 1 Enliven Therapeutics · New York, New York and 44 other locations · NCT05304377

• How olverembatinib is processed in people with liver impairment

  This test gives a single 20 mg dose of olverembatinib to people with different levels of chronic liver impairment and matched healthy volunteers to see how the drug is absorbed, distributed, metabolized, and cleared.

  Recruiting Phase 1 Ascentage Pharma Group Inc. · Suzhou, Jiangsu · NCT07282093

• Dasatinib plus ropeginterferon for newly diagnosed chronic myeloid leukemia in chronic phase

  This study tests whether the drug combination dasatinib and ropeginterferon can help control chronic myeloid leukemia in adults with newly diagnosed disease.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07269470

• Prophylactic DLI-X to Prevent Leukemia Relapse After Transplant

  This first-in-human trial tests a prophylactic DLI-X approach to see if it can prevent relapse after matched sibling or haploidentical stem cell transplant in patients with acute leukemias and related blood disorders.

  Recruiting Phase 1 University of Arizona · Tucson, Arizona · NCT07254793

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.