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Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

NCT04739826 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 491

Last updated 2023-11-03

No results posted yet for this study

Summary

The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.

Conditions

  • CML, Chronic Phase; TKI

Interventions

DRUG

Flumatinib Mesylate

Flumatinib mesylate tablets 600mg qd

DRUG

Nilotinib Pill

Nilotinib Capsules 300mg bid

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2025-01-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04739826 on ClinicalTrials.gov