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A drug, odronextamab, in combination with lenalidomide, to treat follicular lymphoma and marginal zone lymphoma (MZL) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 3

8 Locations

NCT06149286

Clinical Trial Goal


To find out if the combination of odronextamab and lenalidomide is safe and works well to treat follicular lymphoma and MZL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have one of the following that has relapsed or is refractory:
    • Follicular lymphoma
    • MZL
  • Do not have lymphoma in your brain or spinal cord
  • Do not have grade 3b follicular lymphoma. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Lenalidomide is a drug that blocks growth of cancer cells.
Odronextamab is a bispecific antibody that targets CD20 on certain cells. 
Rituximab is a monoclonal antibody that targets CD20 on certain cells.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
  • Group 1 – Odronextamab and lenalidomide
  • Group 2Rituximab and lenalidomide 

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You'll get:
  • Lenalidomide –A pill that you take by mouth
  • Odronextamab –  Group 1 only - Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Rituximab - Group 2 only - Given as IV infusions

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.

The Food and Drug Administration (FDA) has approved rituximab and lenalidomide to treat lymphoma. The FDA has not yet approved odronextamab.

Contacts


Clinical Trials Administrator, 844-734-6643, clinicaltrials@regeneron.com

Locations

David Geffen School of Medicine at UCLARECRUITING

Los Angeles, California

Boca Raton Clinical Research (BRCR) GlobalRECRUITING

Plantation, Florida

Indiana University and Comprehensive Cancer CenterRECRUITING

Indianapolis, Indiana

Hattiesburg ClinicRECRUITING

Hattiesburg, Mississippi

Dartmouth Cancer CenterRECRUITING

Lebanon, New Hampshire

Clinical Research Alliance IncRECRUITING

Westbury, New York

Stony Brook University HospitalRECRUITING

Stony Brook, New York

Prohealth Care IncRECRUITING

Waukesha, Wisconsin

ClinicalTrials.gov record


NCT06149286. First posted on 11/28/23

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