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NCT04980222Active, not recruitingPhase 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

A Phase II Study Evaluating 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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (actual)
First submitted
19 Jul 2021
Start date
22 Mar 2022
Primary completion date
24 Oct 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04980222
EU CT number
2023-504994-19-00
EudraCT number
2021-001647-28

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 46
  • From 22 Mar 2022 to the primary completion date, 24 Oct 2024
  • 20 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • 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
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceCompleted
Centre Henri Becquerel
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Rouen CedexFranceCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
University of Michigan Health System
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Ann ArborUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Westchester
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HarrisonUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Stanford Cancer Institute Inpatient Investigational Pharmacy
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StanfordUnited StatesUnknown status
Stanford Cancer Center
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StanfordUnited StatesUnknown status
Washington University; Wash Uni. Sch. Of Med
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St LouisUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.