Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT01657955
Last Updated: 2012-08-06
Study Results
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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UNKNOWN
PHASE3
96 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Bendamustine Hydrochloride Injection
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 );
Chlorambucil
Interventions
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Bendamustine Hydrochloride Injection
Chlorambucil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shandong Lanjin Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lu G Qiu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hematologic Hospital of Chinese Academy of Medical Sciences
Locations
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Hematologic hospital of Chinese academy of medical sciences
Tianjin, , China
Countries
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Central Contacts
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Lu G Qiu, M.D.
Role: CONTACT
Phone: +86-02223909172
Facility Contacts
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Lu G Qiu, M.D.
Role: primary
Jian J Yu, Master
Role: backup
Related Links
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Related Info
Other Identifiers
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RGN0117
Identifier Type: -
Identifier Source: org_study_id