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

COMPLETEDPHASE2

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

NCT04126681•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 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.

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-CP patients with positive Ph chromosome or BCR-ABL fusion genes.
•3. Resistance and intolerance of first- and second-generation TKIs: defined as resistance or intolerance to imatinib, nilotinib, and dasatinib.
•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. For patients with CML-CP, if they have progressed to AP or BP, they cannot be enrolled after treatment with CML-CP.
•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 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 (22)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Gongdong, China

Nanfang hospital of southern medical university

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

The First affiliated hospital of Guangxi Medical University

Nanning, Guangxi, China

Henan Provincial Oncology Hospital

Zhengzhou, Henan, China

Henan Provincial people's Hospital

Zhengzhou, Henan, China

Tongji Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

October 21, 2019

Primary Completion Date

August 1, 2024

Completion Date

August 1, 2024

Last Updated

March 3, 2025

Enrollment

144

ACTUAL participants

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Interventions

HQP1351

DRUG

Hydroxyurea or Interferon-based therapy

DRUG

Homoharringtonine

DRUG

Imatinib, Dasatinib or Nilotinib

DRUG

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

NCT06119269

Chronic Myeloid Leukemia, Chronic Phase

View study

COMPLETED

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

NCT06516029

Chronic Myeloid Leukemia, Chronic Phase

View study

UNKNOWNPHASE2

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

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: March 3, 2025Data 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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A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

Inclusion Criteria

Exclusion Criteria

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia