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 2026-04-15
24
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Patients with Hodgkin lymphoma (HL) who have relapsed or progressed, including those previously treated with checkpoint inhibitors
- Patients with relapsed HL involving extranodal sites
- Patients not considered candidates for high-dose conventional chemotherapy
- Minimum age of 1 year, with no maximum age limit; includes pediatric and adolescent patients at MD Anderson
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 or Lansky performance status of 50 or higher
- Adequate kidney function appropriate for age unless related to HL
- Total bilirubin less than 2 times upper limit of normal unless due to Gilbert's disease
- Aspartate Aminotransferase (AST) less than 3 times upper limit of normal unless due to lymphoma
- Written informed consent or assent according to MD Anderson policy
- Females must be surgically or biologically sterile or have a negative pregnancy test within 72 hours before treatment and each dose
- Women of childbearing potential must agree to use contraception during the study and for 4 months after last treatment
- Males must be surgically or biologically sterile or agree to use contraception during the study and for 1 month after last treatment
- Males must inform the doctor immediately if partner becomes pregnant and must not donate sperm during the study and for 30 days after last treatment
- Males must use a condom during the study and for 30 days after last treatment
You will not qualify if you...
- Allergy to azacitidine, pembrolizumab, or any components of these drugs
- Active uncontrolled medical conditions including infection, hypertension despite treatment, congestive heart failure NYHA class III/IV, or uncontrolled arrhythmia
- Known infection with HIV or active Hepatitis B or C
- Any medical, psychological, or social condition that may interfere with study participation or safety as judged by investigator
- Pregnant or breastfeeding
- Received a live vaccine within 30 days before planned study treatment
- Current or recent use of immunosuppressive medication within 14 days prior to pembrolizumab, except for specified steroid uses
- Active or prior autoimmune disease within past 2 years, except certain mild conditions not requiring systemic treatment
- Known active central nervous system metastases or carcinomatous meningitis
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David McCall, MD
CONTACT
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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