Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Bendamustine hydrochloride injection; Drug: Chlorambucil

• Registration Number: NCT01109264
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2013-06
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bendamustine Hydrochloride	Bendamustine hydrochloride injection	-
Chlorambucil	Chlorambucil	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	after 3 cycles and 6 cycles

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	December 2013
Duration of Remission (DR)	December 2013
Overall Survival (OS)	December 2013
The incidence and severity of adverse events	Up to 2 years after enrollment

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China