Study on Olverembatinib (HQP1351) for Patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML)

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06423911

Provider View

This clinical trial is testing the effectiveness of a new drug, Olverembatinib, for treating patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML). The study aims to compare Olverembatinib with another drug, Bosutinib, and to see if Olverembatinib can help patients with a specific genetic mutation called T315I.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if Olverembatinib, a new medication, is more effective than Bosutinib in treating patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML) who do not have the T315I mutation. Additionally, the study will assess if Olverembatinib can provide benefits to patients who do have the T315I mutation.

Description

This study is divided into two parts. In Part A, researchers will compare the effectiveness of Olverembatinib to Bosutinib in patients with CP-CML who do not have the T315I mutation. The goal is to see if Olverembatinib can achieve a higher rate of major molecular response (MMR), which is a measure of how well the leukemia is controlled. In Part B, the study will focus on patients with the T315I mutation to determine if Olverembatinib can offer therapeutic benefits. Participants will be monitored for their response to the treatment and any side effects they may experience.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with Chronic Phase Chronic Myeloid Leukemia (CML-CP).
  • For Part A: Must have been treated with at least two approved tyrosine kinase inhibitors (TKIs).
  • For Part B: Must have the T315I mutation at screening.
  • Must have a performance status score of 2 or less, indicating they are able to carry out all self-care but unable to carry out any work activities.
  • Must provide written informed consent before any study procedures.
  • Must have adequate organ function as determined by medical tests.

Exclusion Criteria

  • For Part A only: Must not have had the T315I mutation at any time before starting the study treatment.
  • Must not have an active infection that requires treatment with medication.
  • Must not have gastrointestinal (GI) issues that could affect the absorption of the study drugs.
  • Must not have been previously treated with or have a known allergy to Olverembatinib or its ingredients.
  • Must not have been previously treated with or have a known allergy to Bosutinib or its ingredients.
  • Must not be pregnant or breastfeeding.

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