Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Shandong Lanjin Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Neoplasms; Chronic Lymphocytic Leukemia; Leukemia

Treatments: Drug: Chlorambucil; Drug: Bendamustine Hydrochloride Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657955

RGN0117

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Bendamustine Hydrochloride Injection

Experimental group

Description:

d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.

Treatment:

Drug: Bendamustine Hydrochloride Injection

Chlorambucil

Active Comparator group

Description:

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 );

Treatment:

Drug: Chlorambucil