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Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04591197
Collaborator
(none)
200
Enrollment
1
Location
48.7
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study
    Actual Study Start Date :
    Dec 9, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Dec 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. MMR rates at 12 months [12 monts]

      MMR(BCR/ABL(IS)<0.1%) at 12 months after treating

    Secondary Outcome Measures

    1. VEMR rates at 4 weeks [4 weeks]

      VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age ≥ 18 years old, both male and female;

    2. New Diagnosed Chronic Phase Chronic Myeloid Leukemia.

    3. Within half a year after diagnosis of CML;

    4. Previous TKIs treatment was less than 2 weeks;

    5. The pregnant test of female patients was negative (within 7 days before medication before enrollment);

    6. Informed consent of the patient or his legal representative

    Exclusion Criteria:

    1. T315I mutation is known to exist;

    2. Rare atypical transcript types that cannot be standardized internationally;

    3. Received TKI drugs for more than 2 weeks before enrollment;

    4. Received interferon therapy for more than 3 months before enrollment;

    5. Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)

    6. patients who participate in other clinical studies at the same time;

    7. patients who having had major surgery or not recovered from surgery within 4 weeks;

    8. patients who having history of malignant tumor

    9. Woman who is pregnant or nursing

    10. Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3;

    11. Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).

    12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NanfangH Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    xuna, Associate chief physician, Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT04591197
    Other Study ID Numbers:
    • HS-NF-2020
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Leukemia, Myeloid, Chronic-Phase

    Study Results

    No Results Posted as of Apr 12, 2022