Actively Recruiting
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-18
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Hodgkin lymphoma with relapse or progression
- Prior checkpoint inhibitor treatment is allowed
- Patients with relapsed HL involving extranodal sites
- Not considered candidates for high-dose, conventional chemotherapy
- Minimum age of 1 year, no maximum age limit
- ECOG performance status of 0 to 3 or Lansky performance status of 50 or higher
- Adequate kidney function for age unless related to disease
- Adequate liver function, including total bilirubin less than twice upper limit of normal unless due to Gilbert's disease, and AST less than three times upper limit of normal unless due to lymphoma involvement
- Written informed consent or assent provided
- Females must be biologically or surgically sterile or have a negative pregnancy test within 72 hours before treatment start and each dose
- Women of childbearing potential must use contraception during the study and for 4 months after last treatment
- Males must be biologically or surgically sterile or use contraception during the study and for 1 month after last treatment
- Males must inform the doctor if partner becomes pregnant and avoid sperm donation during study and 30 days after last treatment
You will not qualify if you...
- Allergy to azacitidine, pembrolizumab, or their components
- Active uncontrolled infections or serious heart conditions including uncontrolled hypertension, congestive heart failure NYHA class III/IV, or significant arrhythmia
- Known HIV infection or active Hepatitis B or C
- Medical, psychological, or social conditions that may interfere with participation or safety
- Pregnant or breastfeeding
- Receipt of live vaccine within 30 days before study treatment
- Use of immunosuppressive medication within 14 days before first pembrolizumab dose except for certain steroids and topical treatments
- Active or recent autoimmune diseases within past 2 years, except certain mild conditions not requiring systemic treatment
- Known active central nervous system metastases or carcinomatous meningitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Pembrolizumab by vein over about 30 minutes every 3 weeks and Azacitidine by vein over about 60-90 minutes on Days 1-7 of each 28-day study cycle.
Visits every 3 weeks for Pembrolizumab infusion and additional visits on Days 1-7 of each 28-day cycle for Azacitidine infusion
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David McCall, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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