Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    200
  • sponsor
    Shenzhen Second People's Hospital
Updated on 2 February 2021

Summary

The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

Description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

Details
Condition Imatinib, Flumatinib, Chronic Myeloid Leukemia, Chronic Phase
Treatment Flumatinib
Clinical Study IdentifierNCT04677439
SponsorShenzhen Second People's Hospital
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Diagnosis of CML-CP with Ph+
ECOG performance of 0-2
Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN
Treatment failure after imatinib at 3 or 6 months with BCR-ABL >10%
Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital

Exclusion Criteria

Previously documented T315I mutation
History of TKI treatments except of imatinib
History of undergone major surgery within 4 weeks
Patients unwilling or unable to comply with the protocol
Pregnant or breast-feeding patients
patients with other malignant tumor
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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