NCT04126681

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

A Phase 2, Randomized, Open Label, Pivotal Study to Evaluate the Efficacy and Safety of HQP1351 in CML CP Patients Who Are Resistant and/or Intolerant to First- and Second-Generation Tyrosine Kinase Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. The efficacy of HQP1351 is determined by evaluating the subjects' event free survival (EFS).

Detailed description

This is a phase 2, randomized, open label, pivotal study to evaluate the efficacy and safety of HQP1351 in CML CP patients who are resistant and/or intolerant to first- and second-generation TKIs in China. A total of 141 CML CP patients will be included in this study. After screening, eligible subjects will be randomized by 2:1 ratio to enter HQP1351 therapy cohort and best available therapy (BAT) cohort. When the subjects in the two cohorts reach EFS assessment, they can crossover to contralateral cohort if the investigator and Sponsor think they could be clinically benefited. During treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.

Conditions

• Chronic Myeloid Leukemia, Chronic Phase

Interventions

Type	Name	Description
DRUG	HQP1351	HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I
DRUG	Hydroxyurea or Interferon-based therapy	Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
DRUG	Homoharringtonine	Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
DRUG	Imatinib, Dasatinib or Nilotinib	Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

Timeline

• Start date: 2019-10-21
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2019-10-15
• Last updated: 2025-03-03

Locations

22 sites across 1 country: China