Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
1 other identifier
interventional
147
1 country
1
Brief Summary
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 23, 2013
August 1, 2013
3.3 years
April 19, 2010
August 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
after 3 cycles and 6 cycles
Secondary Outcomes (4)
Progression-free Survival (PFS)
December 2013
Duration of Remission (DR)
December 2013
Overall Survival (OS)
December 2013
The incidence and severity of adverse events
Up to 2 years after enrollment
Study Arms (2)
Bendamustine Hydrochloride
EXPERIMENTALChlorambucil
ACTIVE COMPARATORInterventions
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhixiang Shen, Dr.
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 23, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
August 23, 2013
Record last verified: 2013-08