At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Odronextamab (drug), Rituximab (drug), Cyclophosphamide (drug), Doxorubicin (drug)
- How long the study runs
- Study runs about 69 months (dates as stated)
- About the drug or intervention
- Odronextamab — drug: Odronextamab will be administered by intravenous (IV) infusion · Rituximab — drug: Rituximab will be administered IV, or subcutaneously (SC) · Cyclophosphamide — drug: Cyclophosphamide will be administered IV as part of chemotherapy · Doxorubicin — drug: Doxorubicin will be administered IV as part of chemotherapy · Vincristine — drug: Vincristine will be administered IV as part of chemotherapy · Prednisone/Prednisolone — drug: Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 904
- Started
- 2023-12-13
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for diffuse large b-cell lymphoma (dlbcl)
- • Phase3 - 904 participants
- • This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with diffuse large b-cell lymphoma (dlbcl)
Where?
- • Aberdeen - NHS Grampian: Aberdeen Royal Infirmary
- • Uxbridge - The Hillingdon Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug when combined with chemotherapy * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality of life and ability to complete routine daily activities
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓cancer that can be measured on scans with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
- ✓activity scale (ECOG) performance status ≤2
- ✓Life expectancy ≥ 12 months
- ✓International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
- ✓Adequate blood and organ health, as defined in the protocol.
Who cannot take part
- ✗Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current...
- ✗Another active cancer, significant active disease or medical condition, as described in the protocol
- ✗Peripheral neuropathy Grade ≥3
- ✗Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter,...
- ✗Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
See the full criteria
Where Is This Study? (2 UK sites)
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge UB8 3NN, United Kingdom
Geraldine Landers
thh.research.hillingdon@nhs.net01895 279021/ Ext 3021How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT
