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Report for Clinical Trial NCT02511340

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT02511340 Chronic Myelogenous Leukemia
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Flumatinib mesylate tablet 600 mg qd

Description: Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients
Type: Drug
Group Labels: 1

Flumatinib mesylate tablet 600 mg qd


Primary Outcomes

Measure: Confirmed overall hematologic response(OHR)at 6 months

Time: 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

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. --- T315I ---



HPO Nodes


HPO: