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ACTIVE NOT RECRUITING Phase 3

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

Interventions

  • DRUG Mosunetuzumab
  • DRUG Rituximab
  • DRUG Lenalidomide
  • DRUG Tociluzumab

Study Locations (20)

New York

  • NYU Long Island Hospital — Mineola
  • NYU Langone Ambulatory Care Center — New York
  • Montefiore Medical Center - Montefiore Medical Park — The Bronx
  • Montefiore Medical Center — The Bronx

Indiana

  • Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne
  • Investigative Clinical Research of Indiana, LLC — Noblesville

Michigan

  • University of Michigan Health System — Ann Arbor
  • Cancer & Hematology Center of West Michigan — Grand Rapids

North Carolina

  • Duke University Medical Center — Durham
  • Wake Forest Univ Health Svcs — Winston-Salem

Texas

  • Baylor University Medical Center — Dallas
  • MD Anderson Cancer Center — Houston

California

  • City of Hope Comprehensive Cancer Center — Duarte

Georgia

  • Winship Cancer Institute — Atlanta

Maryland

  • Johns Hopkins Uni — Baltimore

Trial Details

FieldValue
Enrollment Target 478 participants
Start Date 2021-10-27
Est. Completion 2029-12-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04712097

The ClinicalTrials.gov registry entry for NCT04712097 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 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsed or Refractory Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Mosunetuzumab 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: NCT04712097 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Indiana, Michigan. 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 NCT04712097 about?

NCT04712097 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma". This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior system...

What is the current status of trial NCT04712097?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2021-10-27. Estimated completion is 2029-12-31.

What conditions does trial NCT04712097 study?

This clinical trial studies the following conditions: Relapsed or Refractory Follicular 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 NCT04712097?

The interventions under investigation include: Mosunetuzumab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Tociluzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04712097?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04712097 being conducted?

This trial has 20 study locations across California, Georgia, Indiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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