A Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R- GEMOX) Versus R- GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)MedDRA version: 21.0Level: PTClassification code: 10012822Term: Diffuse large B-cell lymphoma refractory Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512537-33-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 265
Histologically-confirmed DLBCL, not otherwise specified or history of transformation of indolent disease to DLBCL, Relapsed or refractory disease, At least one (>= 1) line of prior systemic therapy, At least one bi-dimensionally measurable lesion, Eastern Cooperative Oncology Group performance status of 0, 1 or 2, Adequate hematological function
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, Contraindication to rituximab, gemcitabine or oxaliplatin, Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0 at enrollment, Prior use of polatuzumab vedotin or a gemcitabine + platinum-based agent combination, Enrollment in any previous or ongoing polatuzumab vedotin trial, Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
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
Related Research Topics
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