NCT03883087

A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Chronic Phase

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (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) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major cytogenetic response (MCyR).

Detailed description

This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated HQP1351(40mg, QOD) in CML-CP patients with T315I mutation in China. A total of 40 CML-CP patients will be included in this pivotal study. After screening, eligible subjects will receive oral HQP1351 40mg on a continues once every other day dosing regimen , until disease progression, drug intolerance, or meet other treatment conditions to discontinue the study. During the course of 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	40 mg tablet, taken orally once every other day of a 28-day cycle

Timeline

• Start date: 2019-04-08
• Primary completion: 2024-05-01
• Completion: 2025-02-01
• First posted: 2019-03-20
• Last updated: 2023-04-03

Locations

10 sites across 1 country: China