A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the stud

Trial Details

NCT ID
NCT06149286
Phase
PHASE3
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Odronextamab
  • Lenalidomide
  • Rituximab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Plantation, Florida, United States|26.13421,-80.23184
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Hattiesburg, Mississippi, United States|31.32712,-89.29034
  • Lebanon, New Hampshire, United States|43.64229,-72.25176

Key Eligibility Criteria

  • Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the pro…
  • Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immu…
  • Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imagi…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

For full eligibility, visit ClinicalTrials.gov.

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