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ACTIVE NOT RECRUITING Phase 1

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

NCT04246086 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

Conditions Studied

Interventions

  • DRUG Lenalidomide
  • DRUG Tocilizumab
  • DRUG Mosunetuzumab (IV)
  • DRUG Mosunetuzumab (SC)

Study Locations (20)

Other

  • The First Hospital of Jilin University — Changchun
  • West China Hospital, Sichuan University — Chengdu
  • Fudan University Shanghai Cancer Center — Shanghai
  • Tianjin Medical University Cancer Institute & Hospital — Tianjing
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
  • CHU Rennes - Hopital Pontchaillou — Rennes

Ohio

  • Fairview Hospital — Cleveland
  • Cleveland Clinic — Cleveland
  • Hillcrest Hospital — Mayfield Heights

Tennessee

  • Tennessee Oncology;Chattanooga Oncology & Hematology Associates — Chattanooga
  • Tennessee Oncology PLLC - Franklin — Franklin

California

  • City of Hope National Medical Center — Duarte

Florida

  • University of Miami Miller School of Medicine — Miami

Kentucky

  • Norton Cancer Institute - St. Matthews — Louisville

Louisiana

  • Mary Bird Perkins Cancer Ctr — Baton Rouge

Michigan

  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Trial Details

FieldValue
Enrollment Target 237 participants
Start Date 2020-08-12
Est. Completion 2030-09-06
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04246086

The ClinicalTrials.gov registry entry for NCT04246086 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 237 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 Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Lenalidomide 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: NCT04246086 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Ohio, Tennessee. 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 NCT04246086 about?

NCT04246086 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma". This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of ...

What is the current status of trial NCT04246086?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 237 participants. The study started on 2020-08-12. Estimated completion is 2030-09-06.

What conditions does trial NCT04246086 study?

This clinical trial studies the following conditions: 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 NCT04246086?

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

Who is sponsoring clinical trial NCT04246086?

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 NCT04246086 being conducted?

This trial has 20 study locations across California, Florida, Kentucky, Louisiana, 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