A study to look at how safe and effective glofitamab plus R-CHOP in ctDNA high-risk people with untreated diffuse large B-cell lymphoma
- Conditions
- Diffuse Large B-Cell LymphomaMedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504994-19-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Previously untreated patients with cluster of differential (CD20)-positive DLBCL, including diagnoses by the 2016 World Health Organization (WHO) classification of lymphoid neoplasms, International Prognostic Index (IPI): 1-5, Life expectancy of >=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)
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, Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method