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
- Diseases
- Diffuse large B-cell lymphoma
- 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
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| University of Michigan Health System Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford Cancer Institute Inpatient Investigational Pharmacy Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Washington University; Wash Uni. Sch. Of Med Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
- Interim assessment by circulating tumor DNA in primary mediastinal large B-cell lymphoma: a multicenter LYSA study.Blood Adv · 2026 · PMID 41979332
This page is information, not medical advice. Discuss any trial with your doctor.