Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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.
NCT04680052 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG lenalidomide
- DRUG rituximab
- DRUG tafasitamab
Study Locations (20)
California
- John Muir Health Clinical Research Center — Concord
- Marin Cancer Care — Greenbrae
- The Oncology Institute of Hope and Innovation — Pasadena
- Sharp Memorial Hospital — San Diego
Florida
- Cancer Specialists of North Florida — Jacksonville
- Brcr Medical Center, Inc — Plantation
- Asclepes Research Centers — Weeki Wachee
Connecticut
- Middlesex Hospital Cancer Center — Middletown
- Smilow Cancer Hospital — New Haven
Kentucky
- Baptist Health Lexington — Lexington
- Norton Cancer Institute — Louisville
Maryland
- University of Maryland-Greenebaum Cancer Center — Baltimore
- Cancer Center For Blood Disorders — Bethesda
Georgia
- Northwest Georgia Oncology Centers,P.C — Marietta
Hawaii
- Straub Medical Center — Honolulu
Iowa
- Des Moines Oncology Research Association — Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2028-08-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04680052
The ClinicalTrials.gov registry entry for NCT04680052 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04680052 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04680052 about?
NCT04680052 is a clinical study titled "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.". 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.
What is the current status of trial NCT04680052?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2021-04-15. Estimated completion is 2028-08-09.
What conditions does trial NCT04680052 study?
This clinical trial studies the following conditions: Follicular Lymphoma, Marginal Zone Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04680052?
The interventions under investigation include: placebo (DRUG), lenalidomide (DRUG), rituximab (DRUG), tafasitamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04680052?
This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04680052 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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