LymphomaPhase 2NCT04980222
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 2 study testing Glofitamab, Tocilizumab and Doxorubicin in people with Lymphoma, run by Hoffmann-La Roche at 20 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Glofitamab, Tocilizumab and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 22 Mar 2022to 15 Oct 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
United States10 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Baylor University Medical Center
Dallas, Texas, 75204
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604
University of Iowa
Iowa City, Iowa, 52242
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305-5820
Stanford Cancer Institute Inpatient Investigational Pharmacy
Stanford, California, 94305
Spain4 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, 28041
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
France2 sites
Hopital Henri Mondor
Créteil, 94010
Centre Henri Becquerel
Rouen, 76038
Poland2 sites
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, 80-211
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, 50-367
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
About this study
Official title: 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
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
- Lymphoma
- Being tested
- Glofitamab, Tocilizumab, Doxorubicin, Vincristine, Prednisone
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
TocilizumabDrug
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
DoxorubicinDrug
Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
VincristineDrug
Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
PrednisoneDrug
Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
RituximabDrug
Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
CyclophosphamideDrug
Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab + R-CHOP Immunochemotherapy | Experimental | Participants will receive step-up doses of glofitamab, starting on Day 8 of Cycle 3 (2.5 mg), Day 15 of Cycle 3 (10 mg), then 30 mg glofitamab will be given every three weeks (Q3W) onwards, on Day 8 of Cycles 4-6 and on Day 1 of Cycles 7-10. (cycle length = 21 days)
Participants will receive rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone will be administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days) Receives: Drug: Glofitamab; Drug: Tocilizumab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Treatment Complete Response (EOT CR) Rate
Measured: Up to approximately 24 months
Secondary outcomes (7)
Overall Response Rate (ORR) at the EOT
Measured: Up to approximately 24 months
Progression-free Survival (PFS)
Measured: Up to approximately 24 months
Overall Survival (OS)
Measured: Up to approximately 24 months
Percentage of Participants With Adverse Events (AEs)
Measured: Up to 90 days after the final dose of study treatment
Serum Concentration of Glofitamab
Measured: At pre-defined intervals up to approximately 10 months
Maximum Concentration (Cmax) of Glofitamab
Measured: At pre-defined intervals up to approximately 10 months
Total Exposure (AUC) of Glofitamab
Measured: At pre-defined intervals up to approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start22 Mar 2022
- Primary completion24 Oct 2024
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980222
- Sponsor's protocol ID
- GO43075
- Other IDs
- 2023-504994-19-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2021
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Camus V, Krzisch D, Bruscaggin A, Leveque E, Viennot M, Fornecker LM, Cheminant M, Bailly S, Morschhauser F, Feugier P, Choquet S, Durot E, Carras S, Delette C, Damaj GL, Waultier-Rascalou A, Lebreton P, Le Du K, Galtier J, Houot R, Morineau N, Laribi K, Lebras L, Oberic L, Amorim S, Bocchetta S, Viailly PJ, Rainville V, Ruminy P, Caillot M, Terzi di Bergamo L, Piffaretti D, Pirosa MC, Salehi M, Forestieri G, Drieux F, Veresezan EL, Traverse-Glehen A, Donzel M, Burel L, Bohers E, Lanic MD, Penther D, Becker S, Decazes P, Tonnelet D, Draye-Carbonnier S, Tilly H, Jardin F, Rossi D, Sesques P. Interim assessment by circulating tumor DNA in primary mediastinal large B-cell lymphoma: a multicenter LYSA study. Blood Adv. 2026 Jul 14;10(13):4455-4467. doi: 10.1182/bloodadvances.2025019108.
PubMed 41979332
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04980222
- Acronym / sponsor ID
- GO43075
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab + R-CHOP Immunochemotherapy | Experimental | Drug: Glofitamab, Drug: Tocilizumab, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Rituximab, Drug: CyclophosphamideParticipants will receive step-up doses of glofitamab, starting on Day 8 of Cycle 3 (2.5 mg), Day 15 of Cycle 3 (10 mg), then 30 mg glofitamab will be given every three weeks (Q3W) onwards, on Day 8 of Cycles 4-6 and on Day 1 of Cycles 7-10. (cycle length = 21 days) Participants will receive rituximab, cyclophosphamide, doxorubicin, and vincristine Q3W on Day 1 of Cycles 1-6. Prednisone or prednisolone will be administered daily (QD) on Days 1-5 of Cycles 1-6. (cycle length = 21 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlofitamabParticipants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| TocilizumabParticipants will receive tocilizumab as needed to manage cytokine release syndrome (CRS). | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| DoxorubicinParticipants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| VincristineParticipants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| PrednisoneParticipants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| RituximabParticipants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
| CyclophosphamideParticipants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm. | Drug | Glofitamab + R-CHOP Immunochemotherapy |
Primary outcome
End of Treatment Complete Response (EOT CR) Rate
Time frame: Up to approximately 24 months
7 secondary outcomes
Overall Response Rate (ORR) at the EOT
Time frame: Up to approximately 24 months
Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 90 days after the final dose of study treatment
Serum Concentration of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
Maximum Concentration (Cmax) of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
Total Exposure (AUC) of Glofitamab
Time frame: At pre-defined intervals up to approximately 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41979332Camus V, Krzisch D, Bruscaggin A, Leveque E, Viennot M, Fornecker LM, Cheminant M, Bailly S, Morschhauser F, Feugier P, Choquet S, Durot E, Carras S, Delette C, Damaj GL, Waultier-Rascalou A, Lebreton P, Le Du K, Galtier J, Houot R, Morineau N, Laribi K, Lebras L, Oberic L, Amorim S, Bocchetta S, Viailly PJ, Rainville V, Ruminy P, Caillot M, Terzi di Bergamo L, Piffaretti D, Pirosa MC, Salehi M, Forestieri G, Drieux F, Veresezan EL, Traverse-Glehen A, Donzel M, Burel L, Bohers E, Lanic MD, Penther D, Becker S, Decazes P, Tonnelet D, Draye-Carbonnier S, Tilly H, Jardin F, Rossi D, Sesques P. Interim assessment by circulating tumor DNA in primary mediastinal large B-cell lymphoma: a multicenter LYSA study. Blood Adv. 2026 Jul 14;10(13):4455-4467. doi: 10.1182/bloodadvances.2025019108.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glofitamab, Tocilizumab and Doxorubicin in people with Lymphoma, run by Hoffmann-La Roche at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, France, Poland, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of Treatment Complete Response (EOT CR) Rate (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.