CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.
Study Type
OBSERVATIONAL
Enrollment
112
Patients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy.
Semochkin Sergey
Moscow, Ostrovitianov Str. 1, Russia
Progression-free survival
PFS is defined as the number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of disease progression or death, whichever occurs first. PFS will be compared with its proper historical control (BR as induction without subsequent maintenance).
Time frame: 42 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission \[nPR\] plus partial remission \[PR\]) per the 2008 Modified IWCLL NCI-WG criteria.
Time frame: Approximately 24 months after initial dose of study drug.
Overall Survival (OS)
OS is defined as number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of death.
Time frame: 60 months (6 months induction therapy, 12 months maintenance, 42 months long-term follow-up
Safety evaluations
To determine the safety and tolerability of induction chemotherapy and maintenance therapy separately for two groups as assessed by CTCAE v4.0:
Time frame: Up to 30 months
Health Related Quality of Life (HRQoL)
To determinate the effect of maintenance therapy on HRQoL using the EORTC Core quality of life questionnaire (QOL-C30, version 3.0).
Time frame: Up to 30 months
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