Clinical Trial: NCT04980222
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
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-09-30 |
Study Overview
Brief 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 lymphoma (DLBCL), as the first line of treatment.
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
Conditions
Lymphoma
Intervention / Treatment
- Drug: Glofitamab
- Drug: Tocilizumab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Rituximab
- Drug: Cyclophosphamide
Other Study ID Numbers
- GO43075
- 2023-504994-19-00
- 2023
Start Date (Actual)
2022-03-22
Primary Completion Date (Actual)
2024-10-24
Study Completion Date (Estimated)
2026-10-15
Enrollment (Actual)
46
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2026-09-30 |
Study Overview
Brief 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 lymphoma (DLBCL), as the first line of treatment.
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
Conditions
Lymphoma
Intervention / Treatment
- Drug: Glofitamab
- Drug: Tocilizumab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Rituximab
- Drug: Cyclophosphamide
Other Study ID Numbers
- GO43075
- 2023-504994-19-00
- 2023
Start Date (Actual)
2022-03-22
Primary Completion Date (Actual)
2024-10-24
Study Completion Date (Estimated)
2026-10-15
Enrollment (Actual)
46
Study Type
Interventional
Phase
Phase 2