Trial | NCT04677439  Report issue

Title

Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    200
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.
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.
Study Started
Jan 01
2021
Primary Completion
May 30
2023
Anticipated
Study Completion
Dec 30
2023
Anticipated
Last Update
Mar 16
2022

Drug Flumatinib

600 mg of Flumatinib orally daily for 24 months

Flumatinib Experimental

Criteria 

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.
No Results Posted