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.
← catalyst calendarSponsored by Incyte Corporation (industry) · INCY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
654actual
Sites
261
Countries
Australia, Austria, Belgium +25
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-04-15 | actual | When the study began enrolling |
| Primary completion | 2024-02-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-08-09 | estimated | The whole study's end, after follow-up |
| First posted | 2020-12-22 | actual | When this record first appeared on the registry |
| Results posted | 2025-04-04 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Follicular Lymphoma
- Marginal Zone Lymphoma
Interventions
- Drug: tafasitamab — also filed as INCMOR00208, MOR00208
- Drug: rituximab
- Drug: lenalidomide
- Drug: placebo
Primary outcomes
what the primary-completion date above is the date OFFL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
measured up to approximately 34 months
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
measured up to 2 years
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-04-18 · 1.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-06-25 · 797 KB · SAP_001.pdf
Publications
- PMID 41360064 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · INCY's whole pipeline · Catalyst calendar · Every registered study · What changed