Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Leukemia Neoplasms

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 Injection

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

Group Type EXPERIMENTAL

Bendamustine Hydrochloride Injection

Intervention Type DRUG

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 );

Group Type ACTIVE_COMPARATOR

Chlorambucil

Intervention Type DRUG

Interventions

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Bendamustine Hydrochloride Injection

Intervention Type DRUG

Chlorambucil

Intervention Type DRUG

Other Intervention Names

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Leukeran

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No