Odronextamab with chemo vs rituximab with chemo in untreated DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 study tests odronextamab in combination with standard chemotherapy for adults with previously untreated DLBCL, comparing its effectiveness and safety to the current standard therapy of rituximab plus chemotherapy. The trial has Parts 1A/1B to establish safe dosing, followed by Part 2 to compare effectiveness against the rituximab-based regimen. Eligible participants have CD20+ DLBCL, measurable disease, and adequate organ function, with performance status allowing inclusion. Exclusions include primary CNS lymphoma and other active malignancies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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 is not available or deemed ineligible according to the investigator (Part 1A only)
2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Life expectancy ≥ 12 months
5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
6. Adequate hematologic and organ function, as defined in the protocol.

Key Exclusion Criteria:

1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
2. Another active malignancy, significant active disease or medical condition, as described in the protocol
3. Peripheral neuropathy Grade ≥3
4. 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 anti-lymphoma therapy.
5. 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
6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
7. Allergy/hypersensitivity to study drugs, as described in the protocol
8. 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), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where it's running

• Mayo Clinic - Arizona
  Scottsdale, Arizona, United States Recruiting
• David Geffen School of Medicine at UCLA
  Los Angeles, California, United States Recruiting
• University of California Irvine Medical Center
  Orange, California, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  Indianapolis, Indiana, United States Recruiting
• St Vincent Ascension at Peyton Manning Childrens Hospital
  Indianapolis, Indiana, United States Recruiting

+145 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• CRP regimen for older adults with untreated double‑expressor diffuse large B‑cell lymphoma

  This trial will try the CRP drug combination (chidamide, rituximab, and polatuzumab vedotin) as first-line treatment for older adults with previously untreated double-expressor DLBCL.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07397832

• Testing a new drug combination for relapsed or refractory follicular and marginal zone lymphoma

  This study is testing a new combination of drugs to see if it can help adults with relapsed or hard-to-treat follicular or marginal zone lymphoma feel better compared to standard treatment.

  Recruiting at 167 sites Phase 3 Regeneron Pharmaceuticals · Los Angeles, California and 170 other locations · NCT06149286

• Testing a new drug called odronextamab for treating follicular lymphoma

  This study is testing a new drug called odronextamab to see if it can safely and effectively treat people with follicular lymphoma who haven't received treatment before.

  Recruiting at 145 sites Phase 3 Regeneron Pharmaceuticals · Tucson, Arizona and 189 other locations · NCT06091254

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

  This trial tests whether the combo of chidamide, lenalidomide, and rituximab can help treat newly diagnosed double-expressor DLBCL in people who are elderly or not fit for standard chemotherapy.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07884708

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.