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Chronic Myeloid Leukemia, Chronic PhasePhase 2NCT04126681

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

A Phase 2 study testing HQP1351, Hydroxyurea or Interferon-based therapy and Homoharringtonine in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 22 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia, Chronic Phase
What is being tested?
HQP1351, Hydroxyurea or Interferon-based therapy and Homoharringtonine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
22 sitesChina
Study dates
21 Oct 2019to 1 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
  • CML-CP patients with positive Ph chromosome or BCR-ABL fusion genes.
  • Resistance and intolerance of first- and second-generation TKIs: defined as resistance or intolerance to imatinib, nilotinib, and dasatinib.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Predicted life expectancy of ≥3 months.
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  • 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.
  • 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.
  • Cardiac function index: ejection fraction (EF) > 50%, pulmonary arterial systolic pressure (PASP) ≤50 mmHg.
  • QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females.
  • 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).
  • Willingness and ability to comply with study procedures and follow-up examination.

Who cannot join

  • 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.
  • The patients who received any other investigating drugs within 14 days prior to first administration.
  • For patients with CML-CP, if they have progressed to AP or BP, they cannot be enrolled after treatment with CML-CP.
  • Patients who are currently receiving treatment with a medication that has the potential to interact with research drug.
  • Have previously been treated with ponatinib or HQP1351 (or drugs of similar composition).
  • Absorption disorder syndrome or other diseases affecting oral drug absorption.
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  • 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.
  • Pulmonary systolic pressure (PSP) of echocardiography is more than 50 mmHg, or there is clinical symptom related to pulmonary hypertension.
  • 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.
  • Underwent autologous or allogeneic stem cell transplant.
  • CML-CP patient currently diagnosed as Complete cytogenetic response (CCyR).
  • 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.
  • 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.
  • 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).
  • Have active nervous system (CNS) disease as evidence by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required.
  • History of another primary malignancies.
  • Active symptomatic infection.
  • Known to be allergic to study drug ingredients or their analogues.
  • Female patients with blood β-Human chorionic gonadotropin positive, pregnant or lactating or expecting pregnancy during the study program.
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • First Hospital of Jilin University

    Changchun, Jilin

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Sun Yat-sen University Cancer Center

    Guangzhou, Gongdong

  • Nanfang hospital of southern medical university

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine(hematology dept)

    Hangzhou, Zhejiang

  • The First Affiliated Hospital, Zhejiang University School of Medicine(HSCTdept)

    Hangzhou, Zhejiang

  • Qilu hospital of Shandong University

    Jinan, Shangdong

  • The First affiliated hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • The First affiliated hospital of Guangxi Medical University

    Nanning, Guangxi

  • The Affiliated hospital of Qingdao University

    Qingdao, Shandong

  • Ruijing Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200032

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • Tongji Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Union Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Henan Provincial Oncology Hospital

    Zhengzhou, Henan, 450003

  • Henan Provincial people's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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).

Read the 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.

Being tested
HQP1351, Hydroxyurea or Interferon-based therapy, Homoharringtonine, Imatinib, Dasatinib or Nilotinib
Keywords
Chronic Myeloid Leukemia, HQP1351, CML, CML-CP, Olverembatinib Tablets
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HQP1351Drug

    HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I

  • Hydroxyurea or Interferon-based therapyDrug

    Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

  • HomoharringtonineDrug

    Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

  • Imatinib, Dasatinib or NilotinibDrug

    Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.

Study groups in NCT04126681
Study groupRoleWhat they receive
HQP1351 therapy cohortExperimentalHQP1351 40 mg, taken orally once every other day of a 28-day cycle
Receives: Drug: HQP1351
Best Available Therapy (BAT) cohortActive comparatorBest available therapy (BAT) will be selected by the investigator for each participant.
Receives: Drug: Hydroxyurea or Interferon-based therapy; Drug: Homoharringtonine; Drug: Imatinib, Dasatinib or Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event free survival (EFS)

    EFS is defined as any "event" occurred since randomization, such as disease progression.

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

Secondary outcomes (7)

  1. Complete hematologic response (CHR)

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

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

  2. 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.

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

  3. Complete cytogenetic response (CCyR)

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

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

  4. 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.

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

  5. Progression free survival (PFS)

    PFS is defined as the interval between the first dose date 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.

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

  6. Overall survive (OS)

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

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

  7. Incidence and severity of adverse events

    Adverse events (AEs), and serious AEs (SAEs): Patients treatment related AE, SAE will be assessed according NCI CTCAE Version 5.0.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start21 Oct 2019
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126681
Sponsor's protocol ID
HQP1351CC203
Status last verified
Feb 2025
First submitted
11 Oct 2019
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HQP1351, Hydroxyurea or Interferon-based therapy and Homoharringtonine in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (EFS) (time frame: By the end of Cycle 24 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126681, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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