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NCT04246086 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Follicular Lymphoma, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 1
- Development phase
- 237
- Enrollment target
- 20
- Study locations
NCT04246086 is a Phase 1 study of Follicular Lymphoma that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 237 participants, above the 132-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT04246086, a Phase 1 study of Follicular Lymphoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 237 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2030-09-06 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 132-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (80% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT04246086 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Ohio, Tennessee.
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.
What interventions are being tested in trial NCT04246086?
The interventions under investigation include: Lenalidomide (DRUG), Tocilizumab (DRUG), Mosunetuzumab (IV) (DRUG), Mosunetuzumab (SC) (DRUG).
Who is sponsoring clinical trial NCT04246086?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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