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Chronic Myeloid Leukemia, Chronic PhasePhase 2NCT03883087

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

A Phase 2 study testing HQP1351 in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major cytogenetic response (MCyR). 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
10 sitesChina
Study dates
8 Apr 2019to Feb 2025
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.
  • After any targeted BCR-ABL1 tyrosine kinase inhibitors (TKI) treatment, CML-CP patients with T315I mutation.
  • 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 (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.
  • Cardiac function index: ejection fraction (EF) > 50%, pulmonary arterial systolic pressure (PASP) ≤50 mmHg.
  • Corrected QT interval (QTc) 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 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.
  • The patients who received any other investigating drugs within 14 days prior to first administration.
  • Patients who have progressed to accelerated phase (AP) or blast phase (BP) in the past.
  • 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 prolongation. The patients with well controlled HBP can be considered to 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 remission (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 (HCG)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

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Nanfang Hospital of Southern Medical University

    Guanzhou, Guangdong, 510515

  • Shenzhen Second People's Hospital

    Shenzhen, Guandong

  • The First Hospital Affiliated of Soochow University

    Suzhou, Jiangsu

  • Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin

  • Union Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji medical college Huazhong University of Science and Technology

    Wuhan, Hubei

  • Henan Tumor Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Chronic Phase

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.

Being tested
HQP1351
Keywords
Chronic Myeloid Leukemia,CML, T315I mutation, TKI, CML-CP, HQP1351, Olverembatinib Tablets
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • HQP1351Drug

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

Study groups in NCT03883087
Study groupRoleWhat they receive
HQP1351ExperimentalNot described
Receives: Drug: HQP1351

What is being measured

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

  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.

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

Secondary outcomes (9)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    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 posted20 Mar 2019
  2. Study start8 Apr 2019
  3. Primary completionMay 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03883087
Sponsor's protocol ID
HQP1351CC201
Status last verified
Mar 2023
First submitted
13 Mar 2019
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
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 in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 10 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Results are not available in the source record.

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?

Major cytogenetic response (MCyR) (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 NCT03883087, 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 Apr 2023.

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