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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorM.D. Anderson Cancer Center

About this trial

This study is a Phase II single-center clinical trial designed to assess the efficacy, safety, and tolerability of pembrolizumab in combination with the 7-day regimen of azacitidine for the treatment of relapsed/refractory HL.

Eligibility criteria

Qualifiers

HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed

AML patients with relapse or progression. Patients may receive cytoreduction prior to enrollment for patients with rapidly proliferative disease before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted

Patients with relapsed HL involving extranodal sites

HL patients who are not regarded as a candidate for high-dose, conventional chemotherapy

Disqualifiers

Allergy to azacitidine or pembrolizumab or the drugs' components

Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician

Patients with known infection with human immunodeficiency virus (HIV) or active Hepatitis B or C

Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator

Trial design

Treatments tested in this trial

  • Azacytidine
  • Pembrolizumab

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators