A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a

Trial Details

NCT ID
NCT05675410
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Biospecimen Collection
  • Bleomycin Sulfate
  • Brentuximab Vedotin
  • Computed Tomography
  • Cyclophosphamide
  • Dacarbazine
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Mesa, Arizona, United States|33.42227,-111.82264

Key Eligibility Criteria

  • Patients must be 5 to 60 years of age at the time of enrollment
  • Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-r…
  • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
  • Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI …

For full eligibility, visit ClinicalTrials.gov.

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