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Bendamustine Hydrochloride

Rituximab

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.

BR as Maintenance

Sergey Semochkin, Professor

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.

Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia

Study of Bendamustine and Rituximab as Induction Immunochemotherapy Followed by Maintenance Bendamustine and Rituximab in Relapsed and Refractory B-cell Chronic Lymphocytic Leukemia (CLL)

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).

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.

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.

To determine the safety and tolerability of induction chemotherapy and maintenance therapy separately for two groups as assessed by CTCAE v4.0:

To determinate the effect of maintenance therapy on HRQoL using the EORTC Core quality of life questionnaire (QOL-C30, version 3.0).

Pirogov Russian National Research Medical University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia	NCT03847727	Chronic Lymphoc...	BR as Maintenan...	18 Years -	Pirogov Russian National Research Medical University
Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia	NCT03847727	Chronic Lymphoc...	BR as Maintenan...	18 Years -	Pirogov Russian National Research Medical University

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