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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Flumatinib Chronic Myeloid Leukemia, Chronic Phase Imatinib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flumatinib

Group Type EXPERIMENTAL

Flumatinib

Intervention Type DRUG

600 mg of Flumatinib orally daily for 24 months

Interventions

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Flumatinib

600 mg of Flumatinib orally daily for 24 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No