Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the overall response rate (ORR)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,297 Total Patients Enrolled
David McCall, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe ongoing health issues like uncontrolled infections, heart problems, or high blood pressure.I have not received a live vaccine in the last 30 days.I am at least 1 year old and can be treated at the pediatric/adolescent center.My Hodgkin lymphoma has returned or worsened, but I've had checkpoint inhibitors before.I do not have HIV or active hepatitis B or C.I am allergic to azacitidine, pembrolizumab, or their ingredients.I haven't taken strong immune-suppressing drugs in the last 2 weeks, except for minor exceptions like inhalers or low-dose steroids.My cancer has spread to my brain or the membranes around my brain.My Hodgkin's lymphoma has returned and is affecting areas outside of my lymph nodes.I can take care of myself but may not be able to do any physical work.I have not had any autoimmune diseases except for mild conditions like asthma or vitiligo in the last 2 years.My kidney function is normal for my age, unless it's affected by my condition.I am not considered suitable for intense chemotherapy for my Hodgkin lymphoma.I am not pregnant and can confirm it with a test before treatment.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.I will inform my doctor if my partner becomes pregnant and will not donate sperm or have unprotected sex during and for 30 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab plus Azacitidine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any vacancies still available for this research project?
"Data hosted on clinicaltrials.gov indicates that this medical study is actively searching for participants. Originally posted on October 5th 2022, it was last updated the same day."
Answered by AI
Has the United States Food and Drug Administration sanctioned Pembrolizumab for use?
"Due to the experimental nature of Pembrolizumab, evidence-based safety received a score of 2 out of 3. Although there is some data that suggests its relative security, no efficacy studies have been conducted as yet."
Answered by AI
What is the size of the patient population involved in this scientific investigation?
"Yes, the information on clinicaltrials.gov verifies that this research is currently recruiting participants; it was initially published on October 5th 2022 and updated since then as well. The trial aims to include 24 individuals at one clinic site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger