NCT01503502

A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Phase II Study of Flumatinib Versus Imatinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Detailed description

It is an open-label, randomized, multi-center study in comparison of Gleevec and flumatinib in newly diagnosed (within 6 months) CML patients who are Philadelphia chromosome-positive. One hundred and fifty adult patients will be randomized in 1:1:1 ratio. The planned doses are as follows: 400 mg QD (50 patients) of flumatinib, 600 mg QD (50 patients) of flumatinib, and 400 mg QD (50 patients) of imatinib. Flumatinib will be dosed, based on the food effect results, in fasting condition. Imatinib will be dosed with food per the package insert. The study consists of 2 phases: 6 months of core phase and 6 months of extension phase.

Conditions

• Myelogenous Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	flumatinib	Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.
DRUG	imatinib	Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2014-12-01
• First posted: 2012-01-04
• Last updated: 2013-04-10

Locations

5 sites across 1 country: China