Clinical Trial: NCT02390869
Rituximab and Lenalidomide vs Rituximab Alone as Maintenance After R-chemoterapy for Relapsed/Refractory FL Patients
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Fondazione Italiana Linfomi - ETS |
| Information Provided By: | Fondazione Italiana Linfomi - ETS |
| Last Update Posted: | 2026-08-19 |
Study Overview
Brief Summary
A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
Official Title
A Randomized Phase III Multicenter Trial Assessing Efficacy and Toxicity of a Combination of Rituximab and Lenalidomide (R2) vs Rituximab Alone as Maintenance After Chemoimmunotherapy With Rituximab-chemotherapy (R-CHT) for Relapsed/Refractory FL Patients Not Eligible for Autologous Transplantation (ASCT).
Conditions
Lymphoma, Follicular
Intervention / Treatment
- Drug: R2-MANT
- Drug: R-MANT
Other Study ID Numbers
- FIL_RENOIR12
Start Date (Actual)
2014-05
Primary Completion Date (Actual)
2023-01-25
Study Completion Date (Estimated)
2027-08
Enrollment (Actual)
128
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Fondazione Italiana Linfomi - ETS |
| Information Provided By: | Fondazione Italiana Linfomi - ETS |
| Last Update Posted: | 2026-08-19 |
Study Overview
Brief Summary
A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
Official Title
A Randomized Phase III Multicenter Trial Assessing Efficacy and Toxicity of a Combination of Rituximab and Lenalidomide (R2) vs Rituximab Alone as Maintenance After Chemoimmunotherapy With Rituximab-chemotherapy (R-CHT) for Relapsed/Refractory FL Patients Not Eligible for Autologous Transplantation (ASCT).
Conditions
Lymphoma, Follicular
Intervention / Treatment
- Drug: R2-MANT
- Drug: R-MANT
Other Study ID Numbers
- FIL_RENOIR12
Start Date (Actual)
2014-05
Primary Completion Date (Actual)
2023-01-25
Study Completion Date (Estimated)
2027-08
Enrollment (Actual)
128
Study Type
Interventional
Phase
Phase 3