Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Simcere

Status and phase: Completed; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Bendamustine hydrochloride injection; Drug: Chlorambucil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109264

SIM-79-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Bendamustine Hydrochloride

Experimental group

Treatment:

Drug: Bendamustine hydrochloride injection

Chlorambucil

Active Comparator group

Treatment:

Drug: Chlorambucil