NCT03883087

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 2 Last updated 31 March 2023

What this trial tests

Phase 2 trial testing HQP1351 in Chronic Myeloid Leukemia, Chronic Phase in 41 participants. Status unknown.

Timeline

8 April 2019

Primary endpoint
1 May 2024

1 February 2025

Quick facts

Lead sponsor	Ascentage Pharma Group Inc.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	8 April 2019
Primary completion	1 May 2024
Estimated completion	1 February 2025
Sites	10 locations across China

Drugs / interventions tested

• HQP1351 — full drug profile →

Conditions studied

• Chronic Myeloid Leukemia, Chronic Phase — all drugs for Chronic Myeloid Leukemia, Chronic Phase →

Sponsor

Ascentage Pharma Group Inc. — full company profile →

Who can join

18 and older, any sex, with Chronic Myeloid Leukemia, Chronic Phase. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Major cytogenetic response (MCyR)
  Time frame: By the end of Cycle 24 (each cycle is 28 days)
  MCyR is the proportion of patients achieving Complete cytogenetic response (CCyR: defined as 0% Philadelphia chromosome-positive \[Ph+\] metaphases by cytogenetic analysis of bone marrow) or Partial Cytogenetic Response (PCyR: defined as \>0% to 35% Ph+ metaphases by cytogenetic analysis of bone marrow). It is defined as the best response obtained by the subjects during the whole treatment process

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia-From Molecular Mechanisms to Clinical Relevance.
   Alves R, Gonçalves AC, Rutella S, Almeida AM, et al · · 2021 · cited 112× · PMID 34638304 · DOI 10.3390/cancers13194820
2. Third-line therapy for chronic myeloid leukemia: current status and future directions.
   Cortes J, Lang F. · · 2021 · cited 83× · PMID 33736651 · DOI 10.1186/s13045-021-01055-9
3. Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial.
   Jiang Q, Li Z, Qin Y, Li W, et al · · 2022 · cited 78× · PMID 35982483 · DOI 10.1186/s13045-022-01334-z
4. Novel agents and regimens for hematological malignancies: recent updates from 2020 ASH annual meeting.
   Hou JZ, Ye JC, Pu JJ, Liu H, et al · · 2021 · cited 43× · PMID 33879198 · DOI 10.1186/s13045-021-01077-3
5. Design, synthesis, and biological evaluation of Bcr-Abl PROTACs to overcome T315I mutation.
   Jiang L, Wang Y, Li Q, Tu Z, et al · · 2021 · cited 29× · PMID 34094836 · DOI 10.1016/j.apsb.2020.11.009
6. Potential Approaches <i>Versus</i> Approved or Developing Chronic Myeloid Leukemia Therapy.
   Andretta E, Costa C, Longobardi C, Damiano S, et al · · 2021 · cited 23× · PMID 34993151 · DOI 10.3389/fonc.2021.801779
7. FLT3 inhibition by olverembatinib (HQP1351) downregulates MCL-1 and synergizes with BCL-2 inhibitor lisaftoclax (APG-2575) in preclinical models of FLT3-ITD mutant acute myeloid leukemia.
   Fang DD, Zhu H, Tang Q, Wang G, et al · · 2022 · cited 19× · PMID 34710737 · DOI 10.1016/j.tranon.2021.101244
8. Ponatinib-review of historical development, current status, and future research.
   Kantarjian HM, Chifotides HT, Haddad FG, Short NJ, et al · · 2024 · cited 17× · PMID 38727135 · DOI 10.1002/ajh.27355