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A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT03883100•Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in accelerated phase (CML-AP) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major hematologic response (MaHR).

Detailed Description

This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated of HQP1351(40mg, QOD) in CML-AP patients with T315I mutation in China. A total of 20 CML-AP 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
•2. CML-AP patients with positive Ph chromosome or BCR-ABL fusion genes.
•3. After any targeted BCR-ABL1 tyrosine kinase inhibitors (TKI) treatment, CML-AP patients with T315I mutation.
•4. Ability to understand and willingness to sign a written informed consent form. The consent form must be signed by the patient prior to any study-specific procedures.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
•6. Predicted life expectancy of ≥3 months.
•7. Organ function as indicated by the following laboratory indicators must be met（Hematological indicators require that no blood transfusion or any blood products or cytokines be used within 14 days prior to testing）:
•* Hemoglobin ≥8.0g/dL.
•* White blood cell count ≥ 3.0×10\^9/L.
•* Platelet count ≥ 75×10\^9/L.
+10 more criteria

Exclusion Criteria

•1. Received cytotoxic chemotherapy or radiotherapy within 28 days prior to the first administration, interferon or cytarabine or antitumor effect Chinese herbal medicine or Chinese patent medicine within 14 days prior to the first administration, or targeted BCR-ABL1 TKI within 7 days prior to the first administration, or hydroxyurea or anagrelide within 24 hours after the first administration, or adverse events (except alopecia) caused by previous treatment and have not recovered.
•2. The patients who received any other investigating drugs within 14 days prior to first administration.
•3. Patients who have progressed to blast phase (BP) in the past.
•4. Patients who are currently receiving treatment with a medication that has the potential to interact with research drug.
•5. Have previously been treated with ponatinib or HQP1351 (or drugs of similar composition).
•6. Absorption disorder syndrome or other diseases affecting oral drug absorption.
•7. Have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.
•8. Pulmonary systolic pressure (PSP) of echocardiography is more than 50 mmHg, or there is clinical symptom related to pulmonary hypertension.
•9. Have a history of serious cardiovascular diseases during the previous treatment of chronic myeloid leukemia with TKI, including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure.
•10. Underwent autologous or allogeneic stem cell transplant.
+10 more criteria

Locations (9)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guandong, China

Nanfang hospital of southern medical university

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Henan Tumor Hospital

Zhengzhou, Henan, China

Tongji medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Hospital Affiliated of Soochow University

Suzhou, Jiangsu, China

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

April 8, 2019

Primary Completion Date

April 1, 2024

Completion Date

March 1, 2025

Last Updated

April 3, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Myeloid Leukemia - Accelerated Phase

Interventions

HQP1351

DRUG

Decitabine and HQP1351-based Chemotherapy Regimen for the Treatment Advanced CML

NCT05376852

Chronic Myeloid Leukemia in Myeloid Blast CrisisChronic Myeloid Leukaemia Transformation+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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