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CML, Chronic PhasePhase 4NCT05367765

A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

A Phase 4 study testing Flumatinib and Imatinib in people with CML, Chronic Phase, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib 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 years and older
Conditions the study is for
CML, Chronic Phase
What is being tested?
Flumatinib and Imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteChina
Study dates
30 Apr 2022to 30 Apr 2028
Phase
Phase 4

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

  • Men or women aged more than or equal to (≥) 18 years.
  • Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0~2.
  • Signed and dated Informed Consent Form.

Who cannot join

  • Patients with previously documented T315I mutation.
  • Received BCR-ABL TKI(s) treatment before enrollment.
  • Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
  • Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
  • Pregnant or lactating female.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Ma contact

13304518000

majun0322@126.com

China1 site

  • Institute of Hematology and Oncology, Harbin The First Hospital

    Harbin, Heilongjiang, 201203

    Jun Ma, 13304518000, majun0322@126.com

Other trials in China

About this study

Official title: Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study

Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Read the detailed description

The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China.

The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)

Being tested
Flumatinib, Imatinib
Keywords
Chronic Myeloid Leukemia, Flumatinib, BCR-ABL TKI, Real World, Prospective
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.

  • FlumatinibDrug

    Flumatinib 600mg orally daily

  • ImatinibDrug

    Imatinib 400mg orally daily (Reference drug instructions)

Study groups in NCT05367765
Study groupRoleWhat they receive
Flumatinib mesylate tabletsExperimentalNot described
Receives: Drug: Flumatinib
Imatinib mesylate tabletsActive comparatorNot described
Receives: Drug: Imatinib

What is being measured

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

  1. Major molecular response (MMR) rate at 12 months

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

    Measured: 12 months

Secondary outcomes (7)

  1. MMR rate of high-risk population treated at the end of 12 months

    • High-risk population：Sokal score>1.2
    • MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.

    Measured: 12 months

  2. MMR rate at 6, 24 and 36 Months

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

    Measured: 6, 24 and 36 Months

  3. Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months

    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: 6, 12, 24 and 36 Months

  4. Percentage of participants with transformation-free survival (TFS)

    TFS was defined as the time between the first dose and the date of transition to AP/BP or the last efficacy assessment during treatment.

    Measured: up to 60 Months

  5. Percentage of participants with progression free survival (PFS)

    PFS is defined as the time from the first dose to the date of earliest transition to AP/BC, or the date of death from any cause.

    Measured: up to 60 Months

  6. Percentage of participants with overall survival (OS)

    OS was defined as the time between the first dose and the date of death from any cause.

    Measured: up to 60 Months

  7. Incidence and severity of adverse events (AE)

    Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.

    Measured: From baseline until 28 days after the last dose

Timeline

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

  1. First posted10 May 2022
  2. Study start30 Apr 2022 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367765
Sponsor's protocol ID
HS-10096-401
Status last verified
Apr 2022
First submitted
5 May 2022
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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