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CML, Chronic PhasePhase 4NCT05353205

A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

A Phase 4 study testing Flumatinib mesylate tablets (400mg) and Flumatinib mesylate tablets (600mg) in people with CML, Chronic Phase, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

It's a double-blind , randomized ,multi-center study. The purpose of this study is to explore the efficacy and safety of flumatinib 400mg once daily (QD) versus 600mg QD as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP). Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
CML, Chronic Phase
What is being tested?
Flumatinib mesylate tablets (400mg) and Flumatinib mesylate tablets (600mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
23 Nov 2021to 30 Sep 2025
Phase
Phase 4
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form.
  • Men or women aged more than or equal to (≥) 18 years, and less than (<) 75 years.
  • ECOG performance status of 0-2.
  • Patients with philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.
  • Adequate organ function.
  • Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.
  • Females must have evidence of non-childbearing potential.

Who cannot join

  • Known atypical CML or presence of additional chromosomal abnormalities.
  • Known presence of the T315I mutation.
  • Treatment with tyrosine kinase inhibitor(s) prior to randomization.
  • Any treatment with anti-CML activity for longer than 2 weeks(exception of hydroxyurea or anagrelide) or hematopoietic stem cell transplantation prior to randomization .
  • Prior treatment with splenectomy.
  • Impaired cardiac function including any one of the following:
Show all 27Show fewer
  • Resting corrected QT interval (QTc) > 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,
  • Left ventricular ejection fraction (LVEF) ≤ 50%.
  • During screening period, ECG examination showed average heart rate <50 beats per minute.
  • Myocardial infarction occurred within 12 months of randomization;
  • Congestive heart failure occurred within 6 months of randomization;
  • Uncontrollable angina.
  • Stroke or transient ischemic attack within 6 months of randomization.
  • Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).
  • Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.
  • The presence of active infectious diseases has been known prior to randomization
  • History of significant congenital or acquired bleeding disorders unrelated to CML
  • Inadequate other organ function.
  • History of other malignancies.
  • History of hypersensitivity to any active or inactive ingredient of flumatinib.
  • Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued.
  • Major surgery within 4 weeks of randomization.
  • Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 within 4 weeks of randomization.
  • Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Trial locations and contacts

1 site in 1 country.

Jun Ma contact

13304518000

majun0322@126.com

China1 site, 1 recruiting

  • Institute of Hematology and Oncology, Harbin The First Hospital

    Harbin, Hei Longjiang

    Jun Ma, 13304518000, majun0322@126.com

    Recruiting

Other trials in China

About this study

Official title: A Double-blind , Randomized, Multicenter, Phase 4 Study to Evaluate Efficacy and Safety of Oral Flumatinib 400mg Versus 600mg in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

It's a double-blind , randomized ,multi-center study. The purpose of this study is to explore the efficacy and safety of flumatinib 400mg once daily (QD) versus 600mg QD as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Read the detailed description

This is a dose-optimization study of flumatinib in adult patient with newly diagnosed CML-CP. The objective of this study is to compare the efficacy and safety of flumatinib 400mg QD with that of 600mg QD. Eligible patients are randomized in a 1:1 ratio to receive either fluamtinib 400mg QD or flumatinib 600mg QD. Randomization is stratified based on Sokal risk score (<0.8,0.8~1.2,>1.2). Patients will discontinue study therapy due to treatment failure, disease progression or intolerance to study medication or due to investigator's or participant's decision. The primary efficacy endpoint is the rate of early molecular response , as measured by RQ-PCR at 3 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion.

Being tested
Flumatinib mesylate tablets (400mg), Flumatinib mesylate tablets (600mg)
Keywords
CML, Chronic Phase, Flumatinib, BCR-ABL TKI, Dose-optimization, Double-blind, Phase 4
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.

  • Flumatinib mesylate tablets (400mg)Drug

    Flumatinib 400mg +Placebo for flumatinib are administered orally daily. Patients are randomized to flumatinib 400mg QD.

  • Flumatinib mesylate tablets (600mg)Drug

    Flumatinib 600mg is administered orally daily. Patients are randomized to flumatinib 600mg QD.

Study groups in NCT05353205
Study groupRoleWhat they receive
Flumatinib (400mg)ExperimentalFlumatinib 400mg QD
Receives: Drug: Flumatinib mesylate tablets (400mg)
Flumatinib (600mg)ExperimentalFlumatinib 600mg QD
Receives: Drug: Flumatinib mesylate tablets (600mg)

What is being measured

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

  1. Early molecular response(EMR) rate at 3 months

    Molecular response is assessed using BCR-ABL transcript levels and measured by realtime quantitative polymerase chain reaction(RQ-PCR). Early molecular response is defined as a ratio BCR-ABL/ABL ≤10% on the international scale (IS).

    Measured: 3 months

Secondary outcomes (14)

  1. Major molecular response(MMR) rate at month 3,6,9 and 12

    Major molecular response is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.

    Measured: 3, 6, 9 and 12 months

  2. MR4.0 rate at month 3,6,9 and 12

    MR4.0 is defined as BCR-ABL/ABL ≤0.01% on the international scale.

    Measured: 3, 6, 9 and 12 months

  3. MR4.5 rate at month 3,6,9 and 12

    MR4.5 is defined as BCR-ABL/ABL ≤0.0032% on the international scale.

    Measured: 3, 6, 9 and 12 months

  4. Complete cytogenetic response（CCyR）rate at month 3,6,9 and 12

    Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample . CCyR is defined as 0% Ph+ metaphases in the bone marrow.

    Measured: 3, 6, 9 and 12 months

  5. Complete hematologic response(CHR) rate at month 1,2,3,4,5,6,9 and 12

    Hematologic response will be assessed by complete blood count (CBC) and physical examination at each visit. CHR is defined as all of the following present:

    1. white blood cell(WBC) count <10×109/L
    2. Platelet count <450 ×109/L
    3. Peripheral blood basophils <5%
    4. No blasts and no promyelocytes in peripheral blood
    5. < 5% myelocytes plus metamyelocytes in peripheral blood
    6. No evidence of extramedullary disease, including no splenomegaly or hepatomegaly

    Measured: 1,2,3,4,5,6,9 and 12 months

  6. Time to first MMR

    Evaluate the time from the date of randomization to the date of first documented MMR during treatment.

    Measured: up to 36 months

  7. Time to first CCyR

    Evaluate the time from the date of randomization to the date of first documented CCyR during treatment.

    Measured: up to 36 months

  8. Duration of MMR

    Duration of MMR is defined as the time from the date of first documented MMR to the earliest date of loss of MMR.

    Measured: up to 36 months

  9. Duration of CCyR

    Duration of CCyR is defined as the time from the date of first documented CCyR to the earliest date of loss of CCyR.

    Measured: up to 36 months

  10. Event-free survival (EFS)

    EFS is defined as the time from the date of randomization to the earliest occurrence of the following events: death due to any cause ; loss of CHR ,loss of PCyR ;loss of CCyR ; discontinuation of study treatment due to AE or treatment failure ; progression to AP/BC

    Measured: up to 36 months

  11. Progression-free survival (PFS)

    PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.

    Measured: up to 36 months

  12. Overall survival (OS)

    OS is defined as the time from the date of randomization to the date of death from any cause.

    Measured: Frame:12 and 36 months

  13. The incidence and severity of adverse events ((AE)

    Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v5.0.

    Measured: up to 36 months

  14. Pharmacokinetics (PK) of HS-10096：Tmax

    Serum concentrations of HS-10096 will be collected and analyzed to evaluate the PK of HS-10096.Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (hr).

    Measured: Up to approximately 36 months

Timeline

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

  1. First posted29 Apr 2022
  2. Study start23 Nov 2021
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Sep 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353205
Sponsor's protocol ID
HS-10096-402
Status last verified
Apr 2022
First submitted
22 Apr 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Flumatinib mesylate tablets (400mg) and Flumatinib mesylate tablets (600mg) in people with CML, Chronic Phase, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 7 inclusion and 27 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Jun Ma (13304518000, majun0322@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early molecular response(EMR) rate at 3 months (time frame: 3 months). 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 NCT05353205.

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 29 Apr 2022.

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