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Status unknownNCT03883087Updated Apr 3, 2023

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

A Phase 2 interventional study of HQP1351 in Chronic Myeloid Leukemia, Chronic Phase, sponsored by Ascentage Pharma Group Inc.. Status unknown at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Ascentage Pharma Group Inc. (part of Ascentage Pharma Group International) · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Myeloid Leukemia, Chronic Phase

Keywords

  • Chronic Myeloid Leukemia,CML
  • T315I mutation
  • TKI
  • CML-CP
  • HQP1351
  • Olverembatinib Tablets
03

In context

Leukemia, Myeloid, Chronic-Phase

192 studies on the registry are indexed under Leukemia, Myeloid, Chronic-Phase; 27 are open to participants now.

This study's enrollment of 41 is below the median of 50 across 152 interventional studies indexed under Leukemia, Myeloid, Chronic-Phase.

Browse Leukemia, Myeloid, Chronic-Phase studies →

Lead sponsor

Ascentage Pharma Group Inc. is the lead sponsor of 53 studies on the registry; 31 are open to participants now.

Browse Ascentage Pharma Group Inc. studies →All Ascentage Pharma Group International studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. After any targeted BCR-ABL1 tyrosine kinase inhibitors (TKI) treatment, CML-CP 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.
    • Serum creatinine ≤ 1.5×upper limit of normal (ULN) or 24 hours calculated creatinine clearance ≥ 50mL/min when serum creatinine >1.5×ULN (with Cockcroft-Gault formula).
    • Serum albumin ≥ 3.0 g/dL.
    • Total bilirubin ≤ 1.5 x ULN.
    • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN.
    • Amylase≤1.5×ULN. Lipase≤1.5×ULN.
    • PT、APTT、INR≤1.5×ULN.
  8. Cardiac function index: ejection fraction (EF) > 50%, pulmonary arterial systolic pressure (PASP) ≤50 mmHg.
  9. Corrected QT interval (QTc) on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females.
  10. Males and females of childbearing potential and their partners voluntarily take contraceptive measures that the researchers believe are effective within 120 days from the signing of the informed consent to the last use of the research drug, or confirm that sterilization has been performed (at least one month before screening).
  11. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion criteria

Exclusion Criteria:

  1. Received chemotherapy or radiotherapy within 28 days prior to the first administration, interferon 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 accelerated phase (AP) or 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 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.
  11. CML-CP patient currently diagnosed as Complete cytogenetic remission (CCyR).
  12. Have diseases with abnormal bleeding and coagulation function, or have a bleeding disorder unrelated to CML within 3 months before first dose of study drug.
  13. Underwent major surgery (except minor surgical procedures, such as placement or bone marrow biopsy) with 14 days prior to the first dose of study drug.
  14. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy (It is defined as a daily dose of corticosteroids less than 30 mg prednisone or the same amount of other corticosteroids within 7 days).
  15. Have active nervous system (CNS) disease as evidence by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required.
  16. History of another primary malignancies.
  17. Active symptomatic infection.
  18. Known to be allergic to study drug ingredients or their analogues.
  19. Female patients with blood β-Human chorionic gonadotropin (HCG)positive, pregnant or lactating or expecting pregnancy during the study program.
  20. Suffer from any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    HQP1351

    Drug: HQP1351

Interventions

  • DrugHQP1351

    40 mg tablet, taken orally once every other day of a 28-day cycle

06

What researchers measure

Primary outcomes

  1. Major cytogenetic response (MCyR)

    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 of the study. And MCyR can only be considered as CCyR if the subject meets PCyR at baseline.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

Secondary outcomes

  1. Complete cytogenetic response (CCyR)

    CCyR is the proportion of patients achieving CCyR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  2. Complete hematologic response (CHR)

    CHR requires that all of the following are present: white blood cell\<10×10E9/ liter; blood platelet count\<450×10E9/ liter; no medullary immature granulocytes in the peripheral blood (such as protocell, promyelocyte and myelocyte); basophils in peripheral blood are less than 5%; no disease symptoms, signs and palpable splenomegaly has disappeared; the duration of the above criteria is no less than 4 weeks. We will calculate the proportion of patients achieving CHR after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  3. Major molecular response (MMR)

    MMR is the proportion of patients achieving a ratio of ≤0.1% breakpoint cluster region (BCR) abelson leukemia (ABL) to ABL transcripts on the international scale (≤0.1% BCR-ABL/ABL\[IS\]) after being treated with HQP1351. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  4. BCR-ABL1(IS) transcript ≤1%

    BCR-ABL1(IS) ≤1% is the proportion of patients achieving BCR-ABL1(IS) ≤1% by quantitative polymerase chain reaction detection. It is defined as the best response obtained by the subjects during the whole treatment process of the study.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  5. Time to response

    The time to response is defined as the interval between the first use of HQP1351 and the first date at which the criteria for response are met. The subject who isn't met the response criteria will be censored at the last assessment time.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  6. Duration of response

    Duration of response is defined as the interval between the first assessment at which the criteria for response are met until the earliest date at which the criteria for progression are met, and the subject who isn't met the progression criteria will be censored at the last assessment time. The duration of response is calculated only for subjects who achieved response.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  7. Progression free survival (PFS)

    PFS is defined as the interval between the first dose date of HQP1351 treatment and the first date at which the criteria for progression are met, or death. The subject who isn't progression or death will be censored at the last response assessment.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  8. Overall survive (OS)

    OS is defined as the interval between the first dose date of HQP1351 treatment and date of death, censored at the last contact date to be alive.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  9. Safety: adverse events (AEs), and serious AEs (SAEs)

    Patients with HQP1351 treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

Other outcomes

  1. The relationship between mutation and efficacy.

    During the course of HQP1351 therapy, the relationship between BCR-ABL1 kinase region/other mutations and drug resistance/disease progression will be measured.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

  2. Quality of life (QOL)

    Objects' quality of life will be measured during the course of HQP1351 therapy by European Organization for Research and Treatment quality of life questionnaire core-30 version3.

    Time frame: By the end of Cycle 24 (each cycle is 28 days)

07

Study locations

10 sites
  • Peking University People's Hospital
    Beijing, Beijing Municipality 100044, China
  • Shenzhen Second People's Hospital
    Shenzhen, Guandong, China
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
  • Nanfang Hospital of Southern Medical University
    Guanzhou, Guangdong 510515, China
  • Henan Tumor Hospital
    Zhengzhou, Henan, China
  • Union Hospital medical college Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Tongji medical college Huazhong University of Science and Technology
    Wuhan, Hubei, China
  • The First Hospital Affiliated of Soochow University
    Suzhou, Jiangsu, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
  • Blood Diseases Hospital Chinese Academy of Medical Sciences
    Tianjin, China
08

References and documents

Publications

  • Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. 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. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z. PubMed 35982483 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03883087
Lead sponsor
Ascentage Pharma Group Inc.
Responsible party
Sponsor
First posted
Mar 20, 2019
Start date
Apr 8, 2019
Primary completion
May 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Apr 3, 2023

Study contacts

Xiaojun Huang, Professor
principal investigator · Peking University People's Hospital
Qian Jiang, Professor
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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