This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Obinutuzumab is provided as single-use vials for intravenous administration only. Obinutuzumab 1000mg fixed dose will be administered Chlorambucil would be provided as oral tablet with dose of 0.5mg/kg Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, until 6 cycles.
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
RECRUITINGOverall response rate
iwCLL criteria
Time frame: 3 years
Complete remission rate
No evidence of disease at the time of tumor assessment by NGS method
Time frame: 3 years
Progression free survival
the time from first dose to documented disease progression
Time frame: 3 years
Overall survival
the time from first dose to death from any cause
Time frame: 3 years
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