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Clinical Trials in the USA / NCT04980222
Active, not recruiting Phase 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

NCT04980222 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2022-03-22
Last updated
2026-08-18

Condition(s) studied

Lymphoma

Investigational drug(s) / intervention(s)

Glofitamab →Tocilizumab →Doxorubicin →Vincristine →Prednisone →Rituximab →Cyclophosphamide →

Glofitamab: Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.

Tocilizumab: Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Doxorubicin: Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.

Vincristine: Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.

Prednisone: Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.

Rituximab: Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.

Cyclophosphamide: Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California
Stanford Cancer Center Stanford California
Stanford Cancer Institute Inpatient Investigational Pharmacy Stanford California
University of Iowa Iowa City Iowa
University of Michigan Health System Ann Arbor Michigan
Washington University; Wash Uni. Sch. Of Med St Louis Missouri
Memorial Sloan Kettering Bergen Montvale New Jersey
Memorial Sloan Kettering Cancer Center at Westchester East White Plains New York
Memorial Sloan Kettering Cancer Center New York New York
Baylor University Medical Center Dallas Texas
Aarhus Universitetshospital Skejby Aarhus N Denmark
Hopital Henri Mondor Créteil France
Centre Henri Becquerel Rouen France
Universitair Medisch Centrum Groningen Groningen Netherlands
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii Gdansk Poland
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Wroclaw Poland
Hospital Clinic i Provincial de Barcelona Barcelona BARCELONA
Hospital General Universitario Gregorio Marañon Madrid Madrid
Hospital Univ. 12 de Octubre; Servicio de Hematologia Madrid Madrid
Hospital Clinico Universitario de Salamanca Salamanca SALAMANCA

On this site

📄 Actemra (tocilizumab) drug profile → 📄 Deltasone (prednisone) drug profile → 📄 Rituxan (rituximab) drug profile →

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04980222 on ClinicalTrials.gov ↗ ← All trials in the USA