Clinical trial · Interventional
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
NCT04980222CI-TRIAL-00122485active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Glofitamab | Drug | Glofitamab | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Tocilizumab | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Glofitamab + R-CHOP Immunochemotherapy
- description
- 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)
- interventionNames
- Drug: Glofitamab
- Drug: Tocilizumab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Rituximab
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- End of Treatment Complete Response (EOT CR) Rate
- timeFrame
- Up to approximately 24 months
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCamus 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. PMID 41979332