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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02511340

Enrollment

167

Registered

2015-07-30

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia

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.

Interventions

DRUGFlumatinib mesylate tablet 600 mg qd

Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Confirmed overall hematologic response（OHR）at 6 months	6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026