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New hope for aggressive lymphoma: targeted combo shows promise in early trial

NCT ID NCT04980222

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests a new drug called glofitamab added to standard chemotherapy (R-CHOP) for people with a fast-growing type of lymphoma that has a high risk of coming back. The goal is to see if the combination is safe and helps more patients achieve complete remission. About 46 adults with untreated diffuse large B-cell lymphoma will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses made according to the 2016 World Health Organization (WHO) classification of lymphoid neoplasms * DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well as double-expressor lymphoma (coexpression of MYC and BCL2) * High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 translocations * Patients with de novo transformed follicular lymphoma (patients with discordant bone marrow involvement, i.e., evidence of low-grade histology in bone marrow) may be considered after discussion with the Medical Monitor * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * International Prognostic Index (IPI): 2-5 * Life expectancy of at least 6 months * Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of Cycle 1 and on Day 1 of Cycle 2 submitted for screening for determination of ctDNA status * At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable lymphoma lesion on positron emission tomography/computed tomography (PET/CT) scan * Left ventricular ejection fraction (LVEF) \>=50%, as determined on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematopoietic function * Contraception use Additional Inclusion Criterion for ctDNA High-Risk Participants: * Plasma sample evaluated to be ctDNA high risk Exclusion Criteria: * Current diagnosis of B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma (gray-zone lymphoma), primary mediastinal (thymic) large B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, Burkitt lymphoma, central nervous system (CNS) lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL * Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines, history of severe allergic or anaphylactic reactions to murine monoclonal antibodies, or known sensitivity or allergy to murine products * Prior treatment for indolent lymphoma * Prior solid organ or allogeneic stem cell transplant * Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the exception of palliative, short-term treatment with corticosteroids * Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the final dose of R-CHOP, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of glofitamab

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

Contacts and locations

Locations

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200, Denmark

  • Baylor University Medical Center

    Dallas, Texas, 75204, United States

  • Centre Henri Becquerel

    Rouen, 76038, France

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, BARCELONA, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, SALAMANCA, 37007, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28007, Spain

  • Hospital Univ. 12 de Octubre; Servicio de Hematologia

    Madrid, Madrid, 28041, Spain

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center at Westchester

    East White Plains, New York, 10604, United States

  • Stanford Cancer Center

    Stanford, California, 94305-5820, United States

  • Stanford Cancer Institute Inpatient Investigational Pharmacy

    Stanford, California, 94305, United States

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

    Wroclaw, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdansk, 80-211, Poland

  • Washington University; Wash Uni. Sch. Of Med

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.