Clinical Trial: NCT04680052
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Incyte Corporation |
| Information Provided By: | Incyte Corporation |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Conditions
Follicular Lymphoma, Marginal Zone Lymphoma
Intervention / Treatment
- Drug: tafasitamab
- Drug: rituximab
- Drug: lenalidomide
- Drug: placebo
Other Study ID Numbers
- INCMOR 0208-301
- 2023-504684-16-00
- 2020-004407-13
- 2023
Start Date (Actual)
2021-04-15
Primary Completion Date (Actual)
2024-02-23
Study Completion Date (Estimated)
2028-08-09
Enrollment (Actual)
654
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Incyte Corporation |
| Information Provided By: | Incyte Corporation |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Conditions
Follicular Lymphoma, Marginal Zone Lymphoma
Intervention / Treatment
- Drug: tafasitamab
- Drug: rituximab
- Drug: lenalidomide
- Drug: placebo
Other Study ID Numbers
- INCMOR 0208-301
- 2023-504684-16-00
- 2020-004407-13
- 2023
Start Date (Actual)
2021-04-15
Primary Completion Date (Actual)
2024-02-23
Study Completion Date (Estimated)
2028-08-09
Enrollment (Actual)
654
Study Type
Interventional
Phase
Phase 3