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IDH2 Inhibitor

Enasidenib for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Sara Zarnegar-Lumley
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Second or greater relapse after chemotherapy or hematopoietic stem cell transplant (HSCT)
Relapsed patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with acute myeloid leukemia that's returned or hasn't responded to chemo, and have an IDH2 mutation. They should be able to perform daily activities at least halfway normally, not have certain AML types like Down syndrome-related or t(15;17), no known allergies to enasidenib, and mustn't be pregnant or breastfeeding. Participants need proper kidney function, acceptable blood counts, and can't be on conflicting medications.Check my eligibility
What is being tested?
The trial is testing the effectiveness and side effects of a drug called enasidenib in treating relapsed/refractory acute myeloid leukemia with an IDH2 mutation. It involves collecting biospecimens and performing bone marrow procedures to see if blocking the mutated protein with enasidenib stops cancer growth.See study design
What are the potential side effects?
Enasidenib may cause side effects such as differentiation syndrome (symptoms similar to a flu-like illness), liver problems, increased white blood cell count without infection signs (leukocytosis), nausea, fatigue, joint pain, diarrhea among others. The severity of these side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned after two or more treatments, including chemotherapy or a stem cell transplant.
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My condition has worsened after initial improvement.
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My chemotherapy treatments are considered separate attempts.
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I haven't had re-induction therapy for my current relapse.
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It's been over 21 days since my last antibody treatment and any side effects are mild.
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My condition did not improve after 2 or more initial treatments.
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My AML is IDH2 mutation positive.
Select...
My current condition has no cure or treatment to extend life with good quality.
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It's been over 21 days since I last received treatments like interleukins or interferons.
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It has been more than 42 days since my last cell therapy treatment.
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It's been over 2 weeks since my last corticosteroid dose for immune side effects.
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My kidney function is within the normal range for my age and gender.
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I finished my last cancer treatment over 2 weeks ago and have recovered from its side effects.
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My bilirubin levels are within the normal range for my age.
Select...
My leukemia has relapsed after treatment or is not responding to induction therapy.
Select...
I've had up to two rounds of initial cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration versus time curve of enasidenib
Elimination half-life of enasidenib
Incidence of dose limiting toxicities of enasidenib
+2 more
Secondary outcome measures
Composite complete remission rate (complete remission [CR]/ CR with incomplete hematologic recovery [CRi])
Duration of complete response of enasidenib
Duration of response of enasidenib
+6 more

Side effects data

From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739
71%
Nausea
57%
Fatigue
57%
Diarrhoea
43%
Urinary tract infection
43%
Insomnia
43%
Anaemia
43%
Somnolence
29%
Blood bilirubin increased
29%
Pyrexia
29%
Cough
29%
Leukocytosis
29%
Dry eye
29%
Constipation
29%
Vomiting
29%
Decreased appetite
29%
Hyperbilirubinaemia
14%
Alanine aminotransferase increased
14%
Bacteraemia
14%
Wound complication
14%
Lung infection
14%
Dehydration
14%
Herpes simplex
14%
Hypomagnesaemia
14%
Syncope
14%
Arthralgia
14%
Hyperglycaemia
14%
Oral infection
14%
Contusion
14%
Lymphocyte count decreased
14%
Hypercalcaemia
14%
Hypoxia
14%
Back pain
14%
Thrombocytopenia
14%
Palpitations
14%
Aspiration
14%
Pneumonia aspiration
14%
Apnoea
14%
Respiratory failure
14%
Gait disturbance
14%
Hyponatraemia
14%
Flank pain
14%
Tumour pain
14%
Metabolic encephalopathy
14%
Confusional state
14%
Abdominal discomfort
14%
Pleural effusion
14%
Chills
14%
Productive cough
14%
Nasal congestion
14%
Dysphagia
14%
Angina pectoris
14%
Sinus tachycardia
14%
Abdominal distension
14%
Abdominal pain upper
14%
Flatulence
14%
Salivary hypersecretion
14%
Amylase increased
14%
Aspartate aminotransferase increased
14%
Blood bilirubin unconjugated increased
14%
Blood creatinine increased
14%
International normalised ratio increased
14%
Hypoalbuminaemia
14%
Muscle spasms
14%
Muscle tightness
14%
Muscular weakness
14%
Musculoskeletal pain
14%
Headache
14%
Tremor
14%
Anxiety
14%
Dyspnoea
14%
Oropharyngeal pain
14%
Wheezing
14%
Butterfly rash
14%
Hypertension
14%
Hypotension
14%
Venous thrombosis limb
14%
Conjunctivitis
14%
Oral candidiasis
14%
Pharyngitis
14%
Upper respiratory tract infection
14%
Wound
14%
Hypocalcaemia
14%
Hypokalaemia
14%
Dizziness
14%
Facial paresis
14%
Hemiparesis
14%
Scrotal erythema
14%
Non-cardiac chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enasidenib 400 mg
Enasidenib 100 mg
Enasidenib 200 mg
Enasidenib 650 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (enasidenib)Experimental Treatment5 Interventions
Patients receive enasidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and/or biopsy and collection of blood on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Enasidenib
2020
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,930 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,072 Total Patients Enrolled
Sara Zarnegar-LumleyPrincipal InvestigatorChildren's Oncology Group

Media Library

Enasidenib (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04203316 — Phase 2
Acute Myelogenous Leukemia Research Study Groups: Treatment (enasidenib)
Acute Myelogenous Leukemia Clinical Trial 2023: Enasidenib Highlights & Side Effects. Trial Name: NCT04203316 — Phase 2
Enasidenib (IDH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04203316 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

How many healthcare facilities have adopted this research initiative?

"Patients are being accepted at the State University of New york Upstate Medical University, Arkansas Children's Hospital and Riley Hospital for Children, to name a few among 18 other trial sites."

Answered by AI

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."

Answered by AI
~7 spots leftby Dec 2030