Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109264
• Other study ID #: SIM-79-001
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2010
• Last updated: August 21, 2013
• Start date: March 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Bendamustine hydrochloride injection
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
• Chlorambucil
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		after 3 cycles and 6 cycles	No
Secondary	Progression-free Survival (PFS)		December 2013	No
Secondary	Duration of Remission (DR)		December 2013	No
Secondary	Overall Survival (OS)		December 2013	No
Secondary	The incidence and severity of adverse events		Up to 2 years after enrollment	Yes