NCT01109264

Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Detailed description

Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Bendamustine hydrochloride injection	d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
DRUG	Chlorambucil	d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2010-04-23
• Last updated: 2013-08-23

Locations

1 site across 1 country: China