Spots Global Cancer Trial Database for Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia
Official Title: Study of Bendamustine and Rituximab as Induction Immunochemotherapy Followed by Maintenance Bendamustine and Rituximab in Relapsed and Refractory B-cell Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT03847727
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Semochkin Sergey, Moscow, Ostrovitianov Str. 1, Russian Federation
Contact Details
Name: Sergey Semochkin, Professor
Affiliation: Pirogov Russian National Research Medical University
Role: PRINCIPAL_INVESTIGATOR
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