This trial is active, not recruiting.

Condition chronic myelogenous leukemia
Treatment flumatinib mesylate tablet 600 mg qd
Phase phase 2
Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Start date January 2013
End date August 2015
Trial size 167 participants
Trial identifier NCT02511340, HHGV678-204


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Flumatinib, 600mg, qd
flumatinib mesylate tablet 600 mg qd
Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Primary Outcomes

Confirmed overall hematologic response(OHR)at 6 months
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Male or female patients age 18-75 year-old; - ECOG 0 - 2; - Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase; - Adequate organ function; - Written informed consent prior to any study procedures being performed. Exclusion Criteria: - Patients in Chronic and Blastic Phases; - Previously treated with Flumatinib; - Previously documented T315I mutations; - Previous therapy within protocol defined timeframe, including: - hydroxyurea within 24 hr, - Imatinib or Nilotinib or Dasatinib within 28 days) - Cardiac dysfunction ; - History of congenital or acquired bleeding disorders unrelated to CML; - Central nervous system leukemia; - Previous malignancy except CML; - Acute or chronic liver or severe kidney disease unrelated to CML; - Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Jiangsu Hansoh Pharmaceutical Co., Ltd..