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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 belowSelect...
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.
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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.
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My leukemia has relapsed after treatment or is not responding to induction therapy.
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I've had up to two rounds of initial cancer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreSecondary 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 moreSide effects data
From 2016 Phase 1 & 2 trial • 21 Patients • NCT0227373971%
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
~1720
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
456 Previous Clinical Trials
239,776 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,120 Total Patients Enrolled
Sara Zarnegar-LumleyPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enasidenib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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