Phase II Trial of Azacitidine and Pembrolizumab for Treating Relapsed or Refractory Hodgkins Lymphoma

What this Trial Is About

This research evaluates the combination of pembrolizumab and azacitidine for treating patients with relapsed or refractory classical Hodgkin lymphoma HL. The study aims to assess how well this combination works, its safety, and tolerability in this patient group. It is a Phase II clinical trial conducted at a single center, focusing on patients who have seen their HL return or progress despite prior treatments, including checkpoint inhibitors. Participants receive pembrolizumab intravenously over about 30 minutes every three weeks, along with azacitidine given intravenously for 60 to 90 minutes daily on Days 1 to 7 of each 28-day treatment cycle. This regimen is studied to observe its impact on HL, with no placebo or comparison group. The study includes children and adults without an upper age limit, allowing a broad range of patients to participate. Throughout the study, researchers will monitor participants for overall response rate, duration of response, relapse-free survival, and overall survival. Safety assessments will also be conducted, especially focusing on children. Participants will be evaluated regularly with clinical exams and laboratory tests, and the proportion who proceed to stem cell transplantation after responding to treatment will be recorded. The average follow-up period for response assessment is about one year, with ongoing safety and efficacy monitoring during this time.

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma