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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.
Female patients with infants must agree not to breastfeed their infants while on this study.
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 belowSelect...
I am between 1 and 30 years old.
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I agree not to breastfeed while participating in this study.
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It has been long enough since my last monoclonal antibody treatment.
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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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My AML is not responding to treatment and tests show a small number of cancer cells remain.
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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 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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
2,650 Previous Clinical Trials
4,130,819 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 1 and 30 years old.It has been over 42 days since my last immunotherapy treatment.I agree not to breastfeed while participating in this study.I have recovered from side effects of my previous cancer treatments.I may have cancer spread to my brain or other areas, but haven't had brain radiation during this treatment.It has been long enough since my last monoclonal antibody treatment.It's been over a week since I last used growth factors, and over two weeks since I used Neulasta.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.I had a stem cell transplant less than 100 days ago, or I have active GVHD, or I had severe GVHD in the past, or I am on immune suppression.I have never been treated with nivolumab.My cancer has spread to my brain.My kidney and liver tests are within normal ranges.My AML has returned or is not responding to treatment, with at least 5% cancer cells in my bone marrow.I can start hydroxyurea up to 24 hours before my nivolumab and azacytidine treatment if my white blood cell count is very high.I have confirmed I am not pregnant within the last 24 hours.I agree to use birth control during and up to 7 months after the study.My AML is not responding to treatment and tests show a small number of cancer cells remain.My cancer has returned after treatment or never fully went into remission.I had a stem cell transplant, no severe GVHD, and it's been over 100 days since.I do not have an organ transplant.I am mostly able to care for myself and carry out daily activities.My kidney function is within the normal range for my age and gender.I have AML that developed from a previous blood disorder.I am not planning to receive any non-study treatments like chemotherapy, radiation, or immunotherapy.I do not have a genetic disorder like Fanconi anemia or Bloom syndrome.I have hepatitis B or active hepatitis C.I do not have a history of autoimmune diseases like Crohn's, ulcerative colitis, rheumatoid arthritis, scleroderma, lupus, or Wegener's.I do not have an ongoing infection that isn't improving with treatment.My liver functions are within the required range, or I have an exception due to leukemia.My heart is strong, with good pumping ability.I do not have severe or uncontrolled lung inflammation.I am not allergic to nivolumab or AZA.I have been diagnosed with acute promyelocytic leukemia.I have recovered from previous cancer treatments and it's been over 2 weeks since my last chemotherapy.I have waited over 7 days since my last biologic treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Open label design
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
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