To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China
Objective Response Rate (ORR)
Time frame: after 3 cycles and 6 cycles
Progression-free Survival (PFS)
Time frame: December 2013
Duration of Remission (DR)
Time frame: December 2013
Overall Survival (OS)
Time frame: December 2013
The incidence and severity of adverse events
Time frame: Up to 2 years after enrollment
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