Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05367765

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

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

CML, Chronic Phase Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Hematology and Oncology, Harbin The First Hospital

Harbin, Heilongjiang, 201203, China

Location contact

Jun Ma

CONTACT

[email protected]

13304518000

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Flumatinib

Drug

Flumatinib 600mg orally daily

Imatinib

Drug

Imatinib 400mg orally daily (Reference drug instructions)

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 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.

  2. MMR rate at 6, 24 and 36 Months

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: up to 60 Months

    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.

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

    Time frame: up to 60 Months

    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.

  6. Percentage of participants with overall survival (OS)

    Time frame: up to 60 Months

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

  7. Incidence and severity of adverse events (AE)

    Time frame: From baseline until 28 days after the last dose

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Ma

CONTACT

[email protected]

13304518000

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 10, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.