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

Hansoh Pharma

Status and phase

Unknown

Phase 2

Conditions

Chronic Myelogenous Leukemia

Treatments

Drug: Flumatinib mesylate tablet 600 mg qd

Study type

Interventional

Funder types

Industry

Identifiers

NCT02511340

HHGV678-204

Details and patient eligibility

About

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

Full 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.

Enrollment

167 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.