BRIEF Bendamustine and Rituximab In Elderly Follicular

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT01313611
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab + bendamustine — DRUG
    Induction phase: rituximab and bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, Rituximab on Day 22, bendamustine on Day 29, Bendamustine on Day 30

Study Details

The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden. This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks

Key Dates

Start date
Feb 28, 2011
Status verified
Mar 2018
Primary completion
Oct 31, 2012
Completion
Dec 31, 2017

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + bendamustine

Primary Outcome Measure

Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine [ Time Frame: 12 weeks ]

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