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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note