Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
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Clinical Trial Information
Trial Contact: Parker, Melanie; Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321-843-1036 ; 321.841.5357 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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IRB No: ANHL1931
Protocol Abbrev: ANHL1931
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase III
Age Group: Adult;Pediatric
Secondary Protocol No: ANHL1931
Treatment: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Drug: Etoposide Phosphate; Biological: Filgrastim; Biological: Nivolumab; Biological: Pegfilgrastim; Drug: Prednisolone; Drug: Prednisone; Radiation: Radiation Therapy; Biological: Rituximab; Biological: Rituximab and Hyaluronidase Human; Drug: Vincristine Sulfate
Therapies Involved: Medication; Radiation
ClinicalTrials.gov ID: NCT04759586
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Objective
To determine if nivolumab + chemo-immunotherapy results in a superior long term
PFS (events defined as disease progression confirmed by central review or death)
when compared with chemo- immunotherapy alone in patients with newly diagnosed
primary mediastinal B-cell lymphoma. -
Key Eligibility
Ages Eligible for Study: 2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
