Trials / Completed
CompletedNCT02303119
Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)
A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- The Lymphoma Academic Research Organisation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab IV | intra-venous, 375 mg/m² |
| DRUG | Rituximab SC | sub-cutaneous, 1400 mg |
Timeline
- Start date
- 2015-02-02
- Primary completion
- 2021-06-29
- Completion
- 2021-06-29
- First posted
- 2014-11-27
- Last updated
- 2023-01-10
Locations
50 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02303119. Inclusion in this directory is not an endorsement.