A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapywith Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage Iand II Classic Hodgkin Lymphoma
Sponsor: |
Children's Oncology Group |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU7216 |
U.S. Govt. ID: |
NCT05675410 |
Contact: |
Nobuko Hijiya, MD: 2123059770 / nh2636@cumc.columbia.edu |
This Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60 years with newly diagnosed early-stage cHL and will investigate the targeted CD30-antibody drug conjugate, Brentuximab Vedotin (Bv), with PD-1 blockade (nivolumab) compared with a standard chemotherapy regimen, with or without radiotherapy.
Investigator
Nobuko Hijiya, MD
Are you between 5 and 60 years old? |
Yes |
No |
Do you have newly diagnosed, untreated, histologically confirmed classic Hodgkin lymphoma (cHL) with Stage I or II disease? |
Yes |
No |