Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

Phase 3

• Conditions: Chronic Lymphocytic Leukemia; Leukemia; Neoplasms
• Interventions: Drug: Bendamustine Hydrochloride Injection; Drug: Chlorambucil

• Registration Number: NCT01657955
• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Study First Posted: 2012-08-06
• Last Update Posted: 2012-08-06
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bendamustine Hydrochloride Injection	Bendamustine Hydrochloride Injection	d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.
Chlorambucil	Chlorambucil	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 );

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	24 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	24 months
Progress free survival(PFS)	24 months
Duration of Response (DR)	24 months

Trial Locations

Locations (1)

Hematologic hospital of Chinese academy of medical sciences; 🇨🇳 Tianjin, China