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.
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
Zhixiang Shen, Dr.
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
China: Food and Drug Administration