A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
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: Armatti, Julie M; Parker, Melanie; Frankos, Marie; Torrescano, Tanner; Jones, Jamie; Singh, Sarah H
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-842-8738 ; 321-841-8271 ; 3218412008 ; 321.841.7561
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IRB No: C23.148.08
Protocol Abbrev: AHOD2131
Principal Investigator:
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: AHOD2131
Treatment: Procedure: Biospecimen Collection Biological: Bleomycin Sulfate Drug: Brentuximab Vedotin Procedure: Computed Tomography Drug: Cyclophosphamide Drug: Dacarbazine Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Etoposide Phosphate Other: Fludeoxyglucose F-18 Radiation: Involved-site Radiation Therapy Procedure: Magnetic Resonance Imaging Biological: Nivolumab Procedure: Positron Emission Tomography Drug: Prednisolone Drug: Prednisone Drug: Procarbazine Hydrochloride Other: Questionnaire Administration Drug: Vinblastine Sulfate Drug: Vincristine Sulfate
Therapies Involved: Chemotherapy
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. -
Key Eligibility
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-rich, or lymphocyte-depleted, or not otherwise specified [NOS]) with stage I or II disease
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 allowed if intravenous contrast enhanced CT is also obtained
