Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT02303119
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm). The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could: * optimize rituximab exposure leading to improve response rate * increase adaptative response and then improve long-term control disease.

Key Dates

First listed
Nov 27, 2014
Start date
Feb 2, 2015
Status verified
Jan 2023
Primary completion
Jun 29, 2021
Completion
Jun 29, 2021

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Am A : Rituximab IV
    4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22
  • Experimental: Arm B: Rituximab SC
    1 infusion of intravenous rituximab (375mg/m²) at Day 1, and 7 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
  • Experimental: Arm C : Rituximab SC first cycle
    8 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 5.5 years ]

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