A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients
This trial is active, not recruiting.
|Condition||chronic myelogenous leukemia|
|Treatment||flumatinib mesylate tablet 600 mg qd|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Flumatinib, 600mg, qd
Confirmed overall hematologic response（OHR）at 6 months
time frame: 6 months
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.
|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.|
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