A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
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Clinical Trial Information
Trial Contact: Dubberly, Paige D; Armatti, Julie M; Parker, Melanie; Doyle, Katherine M; Frankos, Marie
Trial Phone: 321-841-7561 ; 321-843-5284 ; 321-843-1036 ; 3218412008 ; 321-842-8738
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IRB No: C23.148.08
Protocol Abbrev: AHOD2131
Principal Investigator:
Phase: Drug: Phase III
Age Group: Pediatric
ClinicalTrials.gov ID: NCT05675410
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Objective
PRIMARY OBJECTIVES:
I. To compare the progression-free survival (PFS) of a standard chemotherapy approach versus an immunotherapy (IO) approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage classic Hodgkin lymphoma (cHL) who have a rapid early response (RER) as determined by position emission tomography post cycle 2 (PET2) after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.
II. To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles of ABVD chemotherapy.