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Anti-metabolites

Azacitidine + Pembrolizumab for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By David McCall, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed
Patients with relapsed HL involving extranodal sites
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination treatment for people with relapsed or refractory Hodgkin lymphoma. The treatment consists of azacitidine and pembrolizumab, and it will be given to patients at a single center. The trial will assess how well the treatment works, how safe it is, and how well patients tolerate it.

Who is the study for?
This trial is for patients with relapsed/refractory Hodgkin's Lymphoma who are not candidates for high-dose chemotherapy. Participants must have certain levels of liver function, agree to contraception if applicable, and can't be pregnant or breastfeeding. Prior treatments with checkpoint inhibitors are allowed, but no recent immunosuppressants or live vaccines.
What is being tested?
The study tests the combination of Azacitidine and Pembrolizumab in treating Hodgkin's Lymphoma that has returned or resisted other treatments. It aims to evaluate how effective and safe this drug duo is when given together over a 7-day regimen.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components, issues from immune system activation such as inflammation in various organs, fatigue, digestive problems, skin reactions, hormonal gland issues (like thyroid), and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Hodgkin lymphoma has returned or worsened, but I've had checkpoint inhibitors before.
Select...
My Hodgkin's lymphoma has returned and is affecting areas outside of my lymph nodes.
Select...
I can take care of myself but may not be able to do any physical work.
Select...
I am not considered suitable for intense chemotherapy for my Hodgkin lymphoma.
Select...
I am not pregnant and can confirm it with a test before treatment.
Select...
I agree to use birth control during and up to 4 months after the study if I'm a woman, or 1 month after if I'm a man.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe ongoing health issues like uncontrolled infections, heart problems, or high blood pressure.
Select...
I do not have HIV or active hepatitis B or C.
Select...
I am allergic to azacitidine, pembrolizumab, or their ingredients.
Select...
My cancer has spread to my brain or the membranes around my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab plus AzacitidineExperimental Treatment2 Interventions
Pembrolizumab 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacytidine
2008
Completed Phase 2
~140
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,303 Total Patients Enrolled
David McCall, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Azacytidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05355051 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Pembrolizumab plus Azacitidine
Hodgkin's Lymphoma Clinical Trial 2023: Azacytidine Highlights & Side Effects. Trial Name: NCT05355051 — Phase 2
Azacytidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355051 — Phase 2
~12 spots leftby Dec 2026
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