A Study to Evaluate the Efficacy and Safety of Glofitamab in Combination with Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Relapsed or refractory diffuse large B-cell lymphomaMedDRA version: 21.0Level: PTClassification code: 10012822Term: Diffuse large B-cell lymphoma refractory Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506899-27-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 245
Life expectancy >= 12 weeks, Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS), Relapsed/refractory disease, At least one line of prior systemic therapy, Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (=> 1 cm) extranodal lesion, as measured on CT scan
Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation, Contraindication to Obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab, History of transformation of indolent disease to DLBCL, High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines, Primary mediastinal B-cell lymphoma, History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
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