Diffuse Large B-Cell Lymphoma MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Glofitamab
Product Code: RO7082859/F04-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Glofitamab
Other descriptive name: RO7082859
Concentration unit:
Sponsors
Roche Farma S.A que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >=18 years at the time of signing Informed Consent Form • 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 o DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well as double-expressor lymphoma (coexpression of MYC and BCL2) o High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 translocations o 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): 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) • Adequate hematopoietic function • Contraception use Additional Inclusion Criterion for ctDNA High-Risk Participants • Plasma sample evaluated to be ctDNA high risk, defined as =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of glofitamab in combination with R-CHOP in circulating-tumor DNA (ctDNA) high-risk patients with previously untreated DLBCL based on end of treatment (EOT) complete response (CR) rate as determined by the investigator according to 2014 Lugano Response Criteria;Secondary Objective: • To evaluate the efficacy of glofitamab in combination with R-CHOP in ctDNA high-risk patients with previously untreated DLBCL based on objective response rate (ORR) at the EOT, progression-free survival (PFS) and overall survival (OS) as determined by the investigator according to 2014 Lugano Response Criteria • To evaluate the safety of glofitamab in combination with R-CHOP in ctDNA high-risk participants with DLBCL • To characterize the serum pharmacokinetics (PK) profile of glofitamab in combination with R-CHOP • To evaluate potential effects of anti-drug antibodies (ADAs);Primary end point(s): 1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma;Timepoint(s) of evaluation of this end point: 1. Up to approximately 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria 3. OS 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events 6. Serum concentrations of glofitamab at specified timepoints 7. Serum trough concentrations of glofitamab at specified timepoints 8. Maximum concentration (Cmax) of glofitamab at specified timepoints 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints 10. Relationship between ADA status and efficacy, safety, or PK endpoints;Timepoint(s) of evaluation of this end point: 1-3. Up to approximately 24 months 4-5. Up to 90 days after the final dose of study treatment 6-10. During treatment (up to approximately 10 months) and at treatment completion/discontinuation visit | — |
Countries
Denmark, France, Netherlands, Poland, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed