Grants and Contracts Details
Primary Objective: To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine). Secondary Objectives: a) To compare overall survival (OS) in patients randomized to N-AVD versus BV- AVD. b) To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD. c) To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD. d) To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups. e) To compare patient-reported symptoms using selected PRO-CTCAE items between arms stratified by age groups. f) To compare the safety and tolerability of N-AVD versus that of BV-AVD.
|Effective start/end date||3/18/21 → 3/17/22|
- Childrens Hospital of Philadelphia: $2.00
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