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A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma
EU CTIS ID: 2024-516904-40-00
What this study is testing
To evaluate the efficacy of polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with respect to progression-free survival (PFS)
- 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
- Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms: – DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type – T-cell/histiocyte-rich large B-cell lymphoma – Epstein-Barr virus-positive DLBCL, NOS – ALK-positive large B-cell lymphoma – HHV8-positive DLBCL, NOS – High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) – High-grade B-cell lymphoma, NOS
- International Prognostic Index (IPI) score of 2-5
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy ≥ 12 months
- At least one bi-dimensionally measurable lesion, defined as >1.5 cm in its longest dimension as measured by computed tomography (CT) or magnetic resonance imaging (MRI)
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
You likely can't join if
- Prior organ transplantation
- Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
- History of indolent lymphoma
- Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1
- Prior radiotherapy to the mediastinal/pericardial region
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Ukraine
- Japan
- Switzerland
- Taiwan
- China
- Russian Federation
- Australia
- Canada
- Brazil
- United States
- Korea, Republic of
- New Zealand
- United Kingdom
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 Turkey; Ukraine; Japan; Switzerland; Taiwan; China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.