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Anti-metabolites

Nivolumab + 5-azacytidine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be ≥ 1 and ≤30 years of age.
Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines or CAR T-cells.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer treatment in children with a certain type of leukemia that has come back or does not respond to other treatments.

Who is the study for?
This trial is for pediatric patients aged 1 to 30 with relapsed/refractory acute myeloid leukemia (AML). Eligible participants may have had multiple treatment attempts or stem cell transplants, provided they meet recovery and organ function criteria. They must not be pregnant, breastfeeding, or have certain infections or autoimmune diseases.Check my eligibility
What is being tested?
The study tests the combination of Nivolumab and 5-azacytidine in children who've seen their AML return after treatment or didn't respond to initial treatments. It's a phase I/II trial aiming to find out how safe this combo is and how well it works against AML.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, liver issues, increased risk of infection due to weakened immunity, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 30 years old.
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It has been over 42 days since my last immunotherapy treatment.
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I agree not to breastfeed while participating in this study.
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I have recovered from side effects of my previous cancer treatments.
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I may have cancer spread to my brain or other areas, but haven't had brain radiation during this treatment.
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It has been long enough since my last monoclonal antibody treatment.
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It's been over a week since I last used growth factors, and over two weeks since I used Neulasta.
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I have not had radiation therapy during this trial, and if I had any to my brain or spine, it was over 90 days ago.
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My kidney and liver tests are within normal ranges.
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I had a stem cell transplant, no severe GVHD, and it's been over 100 days since.
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My AML has returned or is not responding to treatment, with at least 5% cancer cells in my bone marrow.
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I can start hydroxyurea up to 24 hours before my nivolumab and azacytidine treatment if my white blood cell count is very high.
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I have confirmed I am not pregnant within the last 24 hours.
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I agree to use birth control during and up to 7 months after the study.
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My AML is not responding to treatment and tests show a small number of cancer cells remain.
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My cancer has returned after treatment or never fully went into remission.
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I am mostly able to care for myself and carry out daily activities.
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My kidney function is within the normal range for my age and gender.
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I have AML that developed from a previous blood disorder.
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My liver functions are within the required range, or I have an exception due to leukemia.
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My heart is strong, with good pumping ability.
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I have recovered from previous cancer treatments and it's been over 2 weeks since my last chemotherapy.
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I have waited over 7 days since my last biologic treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Toxicity
Remission

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open label designExperimental Treatment2 Interventions
Nivolumab and 5-azacytidine,
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Azacitidine
FDA approved

Find a Location

Who is running the clinical trial?

Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
664 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,234 Total Patients Enrolled

Media Library

5-azacytidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03825367 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Open label design
Acute Myeloid Leukemia Clinical Trial 2023: 5-azacytidine Highlights & Side Effects. Trial Name: NCT03825367 — Phase 1 & 2
5-azacytidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03825367 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this experiment be testing on elderly individuals?

"This clinical study includes a minimum age limit of 1 year old and a maximum age limit of 30 years old."

Answered by AI

Yes, can you tell us about some of the other research that has been done with this treatment?

"This treatment was first studied in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. So far, there have been a total of 408 completed clinical trials related to this topic. Right now, there are 920 ongoing studies actively recruiting patients; many of these are based in Memphis, Tennessee."

Answered by AI

Are people who are interested in this study able to sign up for it right now?

"According to the latest information available on clinicaltrials.gov, this study is no longer recruiting patients. The trial was first posted on 29 November 2019 and updated for the last time on 10 October 2020. There are, however, 924 other trials currently looking for participants."

Answered by AI

How many people are participating in this experiment at most?

"This study is no longer enrolling new patients. According to the latest update on October 10th, 2022, this trial is closed. There are currently 4 other trials for aml patients and 920 other trials seeking participants for this treatment that are still open."

Answered by AI

Could you list the hospitals where this research project is taking place?

"As of now, there are 12 different medical centres that are participating in this trial. A few examples include St. Jude Children's Research Hospital in Memphis, Cook Children's Medical Center in Fort Worth, and Primary Children's Hospital in Salt Lake City."

Answered by AI

What is the standard application of this medication?

"This treatment is commonly used to fight induction chemotherapy, but it can also be helpful in treating other conditions like malignant neoplasms, leukemia, myelocytic, acute, and unresectable melanoma."

Answered by AI

Who would be an eligible candidate for this clinical trial?

"This study is seeking 13 child participants between the ages of 1 and 30 that have been diagnosed with Acute Myeloid Leukemia. To be eligible, potential patients must meet the following conditions: A first or greater relapse, an inability to enter remission after a first or greater relapse, failed induction attempts on two or more occasions, no DNA fragility syndromes such as Fanconi Anemia or Bloom Syndrome, acceptable performance levels based on age. Patients with secondary AML are also eligible so long as they satisfy the other listed requirements."

Answered by AI
~2 spots leftby Mar 2025