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ACTIVE NOT RECRUITING Phase 2

A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

NCT04980222 · View on ClinicalTrials.gov ↗

Study Summary

This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.

Conditions Studied

Interventions

  • DRUG Glofitamab
  • DRUG Doxorubicin
  • DRUG Vincristine
  • DRUG Prednisone
  • DRUG Tocilizumab

Study Locations (18)

Other

  • Aarhus Universitetshospital Skejby — Aarhus N
  • Hopital Henri Mondor — Créteil
  • Centre Henri Becquerel — Rouen
  • Universitair Medisch Centrum Groningen — Groningen
  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii — Gdansk
  • Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku — Wroclaw
  • Hospital Clinic i Provincial de Barcelona — Barcelona
  • Hospital General Universitario Gregorio Marañon — Madrid
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia — Madrid
  • Hospital Clinico Universitario de Salamanca — Salamanca

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • Stanford Cancer Center — Stanford

New York

  • Memorial Sloan Kettering Cancer Center at Westchester — Harrison
  • Memorial Sloan Kettering Cancer Center — New York

Iowa

  • University of Iowa — Iowa City

Missouri

  • Washington University; Wash Uni. Sch. Of Med — St Louis

New Jersey

  • Memorial Sloan Kettering Bergen — Montvale

Texas

  • Baylor University Medical Center — Dallas

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2022-03-22
Est. Completion 2026-09-30
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04980222

The ClinicalTrials.gov registry entry for NCT04980222 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 46 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 Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Glofitamab 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: NCT04980222 reports 18 study locations spanning 7 distinct geographic areas — top geographies include Other, California, New York. 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 NCT04980222 about?

NCT04980222 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma". This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffus...

What is the current status of trial NCT04980222?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2022-03-22. Estimated completion is 2026-09-30.

What conditions does trial NCT04980222 study?

This clinical trial studies the following conditions: 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 NCT04980222?

The interventions under investigation include: Glofitamab (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04980222?

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 NCT04980222 being conducted?

This trial has 18 study locations across California, Iowa, Missouri, New Jersey, New York. 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