A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
2 other identifiers
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 15, 2026
April 1, 2026
4.2 years
April 25, 2022
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the overall response rate (ORR)
through study completion, an average of 1 year
Study Arms (1)
Pembrolizumab plus Azacitidine
EXPERIMENTALPembrolizumab by vein over about 30 minutes every 3 weeks. Azacitidine by vein over about 60-90 minutes on Days 1-7 of each 28-day study cycle
Interventions
Given by Vein (IV)
Eligibility Criteria
You may qualify if:
- HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed
- 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 at MD Anderson (MDA)
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 or Lansky performance status \>= 50
- Adequate renal function per age unless related to the disease
- Total bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease
- Aspartate Aminotransferase (AST) \< 3 x ULN unless considered due to lymphoma involvement
- Provision of written informed consent or assent as per MD Anderson Cancer Center (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
You may not qualify if:
- 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. The following are exceptions to this criterion:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David McCall, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2022
First Posted
May 2, 2022
Study Start
October 5, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04