NCT04408638Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Glofitamab in Combination with Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination with Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Oct 2026
Brief summary (registry, in English)
To evaluate the efficacy of glofitamab (Glofit)- gemcitabine plus oxaliplatin (GemOx) compared with rituximab in combination with gemcitabine and oxaliplatin (R-GemOx) on the basis of overall survival
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 12 Apr 2024
- Start date
- 25 Mar 2021
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Diffuse large B-cell lymphoma
- EU CT number
- 2023-506899-27-00
- EudraCT number
- 2020-001021-31
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 85
- 17 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
Other illness
- History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Other
- Contraindication to Obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
Who the study is looking for
- Life expectancy >= 12 weeks
- Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS)
- Relapsed/refractory disease
- At least one (≥ 1) line of prior systemic therapy
- Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant
- At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (=> 1 cm) extranodal lesion, as measured on computed tomography (CT) scan
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Active, not recruiting |
| Aarhus Universitet Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
Related publications
- Glofitamab plus gemcitabine and oxaliplatin for relapsed/refractory DLBCL: 3-year follow-up of STARGLO.Blood Adv · 2026 · PMID 42269085
This page is information, not medical advice. Discuss any trial with your doctor.