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
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05675410?term=NCT05675410&rank=1
Summary
Primary Outcome Measures:
Progression-free survival (PFS) in rapid early responder (RER) patients [ Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years ]
PFS in slow-early responder (SER) patients [ Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years ]
Secondary Outcome Measures:
Overall survival (OS) in RER patients [ Time Frame: Time of randomization to death, assessed up to 12 years ]
OS in SER patients [ Time Frame: Time of randomization to death, assessed up to 12 years ]
OS for entire population [ Time Frame: At 12 years ]
PFS for favorable risk patients [ Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years ]
PFS for unfavorable risk patients [ Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years ]
PFS for entire population [ Time Frame: Time from randomization to the first event (disease progression, relapse or death), assessed up to 3 years ]
Event-free survival (EFS) [ Time Frame: Time from randomization to the first event (disease progression, relapse, subsequent malignant neoplasms, or death), assessed up to 12 years ]
Incidence of adverse events (AEs) [ Time Frame: Assessed up to 12 years ]
Patient reported outcomes (PROs) [ Time Frame: Assessed up to 12 years ]
Patient-reported fatigue [ Time Frame: At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy ]
Patient-reported cognitive deficits [ Time Frame: At baseline, during chemotherapy (cycle 2, day 1), at completion of therapy (time 0 of follow up) and at 1 and 4 years post completion of therapy ]
Patient-reported health-related quality of life [ Time Frame: Assessed up to 12 years ]
Incidence of self-reported late morbidities [ Time Frame: Assessed up to 12 years ]
Effect of metabolic tumor burden (MTV) on PFS [ Time Frame: At baseline ]
Effect of total lesion glycolysis (TLG) on PFS [ Time Frame: At baseline ]
Contribution of social determinants of health (SDOH) to initial response to therapy by race/ethnicity [ Time Frame: Assessed up to 12 years ]
Contribution of SDOH to PFS by race/ethnicity [ Time Frame: Assessed up to 12 years ]
Contribution of SDOH to OS by race/ethnicity [ Time Frame: Assessed up to 12 years ]