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Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

NCT ID: NCT01109264

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Keywords

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Chronic Lymphocytic Leukemia Bendamustine Hydrochloride Chlorambucil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bendamustine Hydrochloride

Group Type EXPERIMENTAL

Bendamustine hydrochloride injection

Intervention Type DRUG

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

Chlorambucil

Group Type ACTIVE_COMPARATOR

Chlorambucil

Intervention Type DRUG

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Interventions

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Bendamustine hydrochloride injection

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

Intervention Type DRUG

Chlorambucil

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhixiang Shen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SIM-79-001

Identifier Type: -

Identifier Source: org_study_id