Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

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

Detailed Description
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Bendamustine hydrochloride injection
* Drug: Chlorambucil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine Hydrochloride<br> | Drug: Bendamustine hydrochloride injection<br>* d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles<br>|
| Active Comparator: Chlorambucil<br> | Drug: Chlorambucil<br>* d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | after 3 cycles and 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil