Phase II Study of Azacitidine and Pembrolizumab for Relapsed/Refractory Hodgkin's Lymphoma
This study is testing a combination of two drugs, Azacitidine and Pembrolizumab, for people with Hodgkin's Lymphoma that has come back or not responded to previous treatments. Pembrolizumab works by targeting a specific mechanism in the body called a checkpoint inhibitor. The study aims to see how many patients respond to this treatment. You may be able to join if you have Hodgkin's Lymphoma that has relapsed or progressed, even if you've had checkpoint inhibitor treatments before. The study plans to enroll 24 participants. The overall response rate will be measured over about one year to see how well the treatment works.
- Study design
- This is a Phase II study, meaning it's an early-stage study to see how well a new treatment works and if it's safe. It is a single-center study, planning to include 24 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The overall response rate will be measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05355051
A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
Recruiting
PHASE2Ages 1+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~24 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:AzacytidinePembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the overall response rate (ORR)
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- David McCall, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Age of enrollment: Minimum age 1 year. No maximum age, study will include anyone in the pediatric/adolescent center
Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 or Lansky performance status \>= 50
Adequate renal function per age unless related to the disease
Adequate hepatic function including total bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease, and AST \< 3x ULN unless considered due to lymphoma involvement.
Provision of written informed consent or assent as per MDACC policy for study subjects.
Females must be surgically or biologically sterile or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment and each subsequent dose.
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 1 month after the last treatment
Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 30 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 30 days after the last treatment
Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
Has known active central nervous system metastases and/or carcinomatous meningitis
Exclusion
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
Pregnant or breastfeeding
Has received a live vaccine within 30 days of planned start study therapy
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of pembrolizumab.
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication)
What this trial measures
- To assess the overall response rate (ORR)through study completion, an average of 1 year