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NCT04680052 · ClinicalTrials.gov registry record · Phase 3

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.

A Phase 3 study of Follicular Lymphoma and Marginal Zone Lymphoma, sponsored by Incyte Corporation.

Active
Registry status
Phase 3
Development phase
654
Enrollment target
20
Study locations

NCT04680052 is a Phase 3 study of Follicular Lymphoma and Marginal Zone Lymphoma that is active but no longer recruiting, run by Incyte Corporation. The registered enrollment target is 654 participants, above the 128-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (411% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04680052, a Phase 3 study of Follicular Lymphoma and Marginal Zone Lymphoma, is active but no longer recruiting, sponsored by Incyte Corporation.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
654 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 654 participants
Start Date 2021-04-15
Est. Completion 2028-08-09
Phase Phase 3

Sponsor

Incyte Corporation

239 total trials

What the Registry Record Tells You About NCT04680052

The ClinicalTrials.gov registry entry for NCT04680052 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 128-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (411% higher). The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

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.

NCT04680052 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Connecticut.

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.

What interventions are being tested in trial NCT04680052?

The interventions under investigation include: placebo (DRUG), lenalidomide (DRUG), rituximab (DRUG), tafasitamab (DRUG).

Who is sponsoring clinical trial NCT04680052?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.