Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (ORR)
after 3 cycles and 6 cycles
No
Zhixiang Shen, Dr.
Principal Investigator
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
China: Food and Drug Administration
SIM-79-001
NCT01109264
March 2010
December 2013
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