Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

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, Leukemia, Neoplasms

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; No prior or no standard treatment for CLL; Binet stage B, C or symptomatic stage A; Needs treatment to control diseases; (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2 Life expectancy ≥3 months Written informed consent Exclusion Criteria: Patients were diagnosed with or treated for malignant tumors other than CLL (including active 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 Alanine aminotransferase(ALT)>3 times upper limits of normal value, Aspartate aminotransferase(AST)>3 times upper limits of normal value, Total bilirubin(TBIL)>2 times upper limits of normal value, serum creatinine>1.5 times upper limits of normal value; Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases; Serious or uncontrolled infections; Central nervous system dysfunction with clinical symptoms; Patients received major surgery within 30 days prior to study entry; Pregnant or lactating women Allergic to study drug or mannitol Participation in any other clinical trials within 3 months prior to study entry

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 Injection<br>d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles. | Drug: Bendamustine Hydrochloride Injection<br> <br> |
| Active Comparator: Chlorambucil<br>d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC≥4×109 /L at d12-d14 ); d1-d2, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC<4×109 /L at d12-d14 ); | Drug: Chlorambucil<br> <br> * Other names: Leukeran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival(PFS) |  | 24 months | 
| Duration of Response (DR) |  | 24 months | 
| Overall Survival(OS) |  | 24 months |