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Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)

NCT02303119 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2023-01-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rituximab IV

intra-venous, 375 mg/m²

DRUG

Rituximab SC

sub-cutaneous, 1400 mg

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Guillaume Cartron, MD PhD · Lymphoma Study Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303119 on ClinicalTrials.gov