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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
EU CTIS ID: 2024-512537-33-00
What this study is testing
To evaluate the efficacy of Pola-R-GemOx compared with R-GemOx alone on basis of the overall survival (OS) (Stage 2) To evaluate the safety and tolerability of Polatuzumab Vedotin (Pola)-R-GemOx as a combination therapy on basis of incidence, nature and severity of physical findings and adverse events (AEs), with a specific focus on peripheral neuropathy (PN), according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) (Stage 1)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Korea, Republic of
- Canada
- United Kingdom
- Brazil
- China
- India
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Korea, Republic of; Canada; United Kingdom; Brazil; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.