Spots Global Cancer Trial Database for A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

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Trial Identification

Brief Title: A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

Official Title: Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients

Study ID: NCT02511340

Conditions

Chronic Myelogenous Leukemia

Interventions

Flumatinib mesylate tablet 600 mg qd

Study Description

Brief Summary: Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Detailed Description: Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.