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Compares treatment options for Diffuse Large B-cell Lymphoma (DLBCL)
Official title A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06091865
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
Also referred to as REGN1979, Ordspono™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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").
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed...
- Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
- Eastern Cooperative Oncology Group (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
You likely can't join if
- Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
- Another active malignancy, significant active disease or medical condition, as described in the protocol
- Peripheral neuropathy Grade ≥3
- Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL...
- Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
- Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
See the full eligibility criteria
- Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy...
- Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
- Eastern Cooperative Oncology Group (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 hematologic and organ function, as defined in the protocol. Key
- Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
- Another active malignancy, significant active disease or medical condition, as described in the protocol
- Peripheral neuropathy Grade ≥3
- Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic...
- Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
- Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
- Allergy/hypersensitivity to study drugs, as described in the protocol
- Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV)...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Indianapolis, Indiana, United States
- Noblesville, Indiana, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- New Brunswick, New Jersey, United States
- Stony Brook, New York, United States
- Westbury, New York, United States
- Durham, North Carolina, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Ogden, Utah, United States
- Waukesha, Wisconsin, United States
- Liverpool, New South Wales, Australia
+ 127 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Sacramento, California, United States; Indianapolis, Indiana, United States; Noblesville, Indiana, United States; Lexington, Kentucky, United States and 141 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 ClinicalTrials.gov; the study team decides eligibility.