Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma

Sponsor
National Research Center for Hematology, Russia
Study ID
NCT02423837
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

* To evaluate the efficacy of bendamustine in combination with rituximab as first line in patients with follicular lymphoma, 1-3A cytological type. * To evaluate the safety, tolerability and feasibility of bendamustine in combination with rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type. * To evaluate the impact of the regimen modification (bendamustine dose modification and/or extension of inter-cycle interval) into duration of complete and partial responses. * To evaluate estimated treatment duration, reasons of treatment withdrawal. * To evaluate the possibility of unification and standardization of therapy protocol BR (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2). * To evaluate factors affecting overall and progression-free survival.

Key Dates

Start date
Dec 31, 2013
Status verified
Apr 2015
Primary completion
Feb 29, 2016
Completion
Apr 30, 2021

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Efficacy (tumor size evaluation) [ Time Frame: From date of randomization until ending of first line R-B therapy (up to 6 months) ]

Central Contacts

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