Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

NCT ID: NCT01109264

Last Updated: 2013-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine Hydrochloride

Group Type: EXPERIMENTAL

Bendamustine hydrochloride injection

Intervention Type: DRUG

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

Chlorambucil

Group Type: ACTIVE_COMPARATOR

Chlorambucil

Intervention Type: DRUG

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Interventions

Bendamustine hydrochloride injection

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

Intervention Type: DRUG

Chlorambucil

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have a diagnosis of CLL according to National Cancer Institute (NCI) Working Group criteria
• No prior treatment for CLL
• Binet stage B or C
• ECOG performance status ≤ 2
• Life expectancy ≥3 months
• AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min
• Written informed consent

Exclusion Criteria

• Patients were diagnosed with or treated for malignant tumors other than CLL (including central nervous system lymphoma) within one year prior to entering the study
• Transformation to Richter's syndrome, or prolymphocytic leukemia (PLL)
• Autoimmune hemolytic anemia requiring glucocorticoid therapy
• Autoimmune thrombocytopenia requiring glucocorticoid therapy
• Participation in any other clinical trials within 4 weeks prior to study entry
• Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction
• Patients received major surgery within 30 days prior to study entry
• Pregnant or lactating women
• Allergic to study drug or mannitol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhixiang Shen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

SIM-79-001

Identifier Type: -

Identifier Source: org_study_id