A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE >/= 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Kallam, Avyakta
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03907488?cond=NCT03907488&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures :
1. Progression free survival (PFS) [ Time Frame: From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed at 2 years ]
Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.
Secondary Outcome Measures :
1. Overall survival [ Time Frame: 2 years ]
2. Event-free survival (EFS) [ Time Frame: From date of registration to date of first occurrence of EFS event, assessed at 2 years ]
Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.
3. Metabolic complete response rate [ Time Frame: Up to 10 years ]
Defined using 2014 Lugano classification.
4. Incidence of adverse events [ Time Frame: Up to 10 years ]
Toxicity will be evaluated using Common Terminology Criteria of Adverse Events (CTCAE) version 5 items. Treatment-related toxicities between arms will be compared using Fisher's exact test stratified by age groups. Targeted patient-reported toxicities also will be collected at each time point using the Patient Reported Outcome (PRO)-CTCAE for patients 18 years and older and from youth 12-17 years, using the Pediatric (Ped) PRO-CTCAE.