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Nivolumab + 5-azacytidine for Acute Myeloid Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Open label design
- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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