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Enasidenib for Acute Myeloid Leukemia
Study Summary
This trial is testing the side effects of enasidenib and how well it works in treating patients with acute myeloid leukemia that has come back after treatment or has been difficult to treat with chemotherapy.
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.Side effects data
From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739Trial Design
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- I consider my donor lymphocyte infusion as a re-treatment effort.My chemotherapy treatments are considered separate attempts.I haven't taken any cancer drugs that lower blood counts in the last 7 days.I haven't had re-induction therapy for my current relapse.I have waited the required time after my radiation therapy before joining this trial.I can do most activities myself, even if I use a wheelchair.It's been over 21 days since my last antibody treatment and any side effects are mild.My condition did not improve after 2 or more initial treatments.I am not on any cancer treatments, except possibly hydroxyurea for leukemia.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I have recovered from previous cancer treatments and meet the required health criteria.My AML is IDH2 mutation positive.My current condition has no cure or treatment to extend life with good quality.It's been over 21 days since I last received treatments like interleukins or interferons.It has been more than 42 days since my last cell therapy treatment.I had a stem cell transplant more than 60 days ago or a stem cell infusion over 4 weeks ago without signs of GVHD.My AML is not linked to Down syndrome or t(15;17).My cancer has returned after two or more treatments, including chemotherapy or a stem cell transplant.I am not pregnant or breastfeeding and agree to use birth control during and after the study.My condition has worsened after initial improvement.It's been over 2 weeks since my last corticosteroid dose for immune side effects.My kidney function is within the normal range for my age and gender.I haven't had re-induction therapy for my current cancer relapse.I finished my last cancer treatment over 2 weeks ago and have recovered from its side effects.My bilirubin levels are within the normal range for my age.My leukemia has relapsed after treatment or is not responding to induction therapy.It has been more than 42 days since my last radiopharmaceutical treatment.I am not taking certain medications or have switched to alternatives well before starting the trial.I have not taken any cancer drugs known to lower my blood cell counts recently.I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.I have waited the required time after my last growth factor dose before joining the study.I finished my intrathecal chemotherapy more than 3 days ago.I can swallow pills without any issues.I've had up to two rounds of initial cancer treatment.I have never taken enasidenib or any IDH2 inhibitor.You have tried other treatments before and they did not work for you.My platelet count is at least 20,000 and I can have transfusions if needed.My hemoglobin level is at least 8.0 g/dL, even if I needed a transfusion.It's been over 14 days or 5 half-lives since my last dose of a small molecule investigational drug.My leukemia has not spread to my brain or spinal cord, or it's treated if it has.My cancer did not respond after up to two rounds of initial treatment.I am not currently taking any experimental drugs.
- Group 1: Treatment (enasidenib)
- 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
Has Enasidenib been the subject of any other research endeavors?
"Initially researched in 2011 by Memorial Sloan Kettering Cancer Center, enasidenib has since seen 128 trials to completion. Currently, 53 active studies are recruiting patients across the nation - primarily in Syracuse, New york."
What medical condition is Enasidenib usually prescribed to treat?
"Enasidenib is frequently deployed in invasive operations, but has also been found to be effective for treating hypertensive disease, skin disinfection therapy and benign prostatic hyperplasia (BPH)."
What are the eligibility requirements for enrollment in this investigation?
"This clinical trial is recruiting 10 participants aged between 24 months and 18 years old with myeloid leukemia. Furthermore, they must have experienced second or subsequent relapse after either chemotherapy treatment or hematopoietic stem cell transplant (HSCT); be refractory to >=2 induction therapy attempts; not received any re-induction therapies for this particular relapse; Karnofsky performance score of >50% if over 16 year olds and Lansky > 50% if younger than that age bracket; and ambulatory ability in some capacity, including wheelchair use."
What potential hazards exist for individuals taking Enasidenib?
"Our team at Power rates the safety of Enasidenib as a 2 due to its Phase 2 status, which indicates prior clinical data proving safety but no evidence on efficacy."
What goals are researchers aiming to achieve through this investigation?
"The main evaluation metric of this trial, measured over a year-long period post last dose, is the area under enasidenib's plasma concentration curve. Other key statistics include median time to remission and death with 95% confidence intervals as well as frequency (%) of patients that have achieved at least partial response per dosage level."
Does this clinical research encompass the geriatric population?
"Prospective participants of this research must be between the age span of 2 years to 18 years. Clinical trials for those younger than 18 number 448 and 1220 studies are available for patients above 65."
To what extent is this clinical trial enrolling participants?
"Unfortunately, this particular medical study is no longer recruiting patients. Initially posted on March 30th 2020 and last updated September 1st 2022, the trial has reached its desired enrolment count. However, there are still 1466 trials actively searching for participants with myeloid leukemia and 53 studies looking to recruit people taking Enasidenib."
Is enrollment for this clinical trial still ongoing?
"According to the data published on clinicaltrials.gov, this medical trial is not currently accepting applications as its last update was made in September 1st 2022. Nonetheless, there are 1519 other trials actively recruiting individuals for participation at present."
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