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Enasidenib for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Amir t Fathi, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 days 1, 8, and 15; day 1 of cycles 2-12 (1 cycle is 28-days), up to 1 year of total follow-up
Awards & highlights

Study Summary

This trial is testing whether enasidenib can help treat patients with IDH2-mutant leukemia who are undergoing hematopoietic stem cell transplantation.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 days 1, 8, and 15; day 1 of cycles 2-12 (1 cycle is 28-days), up to 1 year of total follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 days 1, 8, and 15; day 1 of cycles 2-12 (1 cycle is 28-days), up to 1 year of total follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of participants with dose limiting toxicities (DLT)
Secondary outcome measures
Graft-vs-Host Disease
Cumulative incidence of chronic GVHD
IDH Mutational burden via next-generation sequencing
+3 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: EnasidenibExperimental Treatment1 Intervention
Enasidenib will be administered orally once daily in 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enasidenib
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,422 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,948 Total Patients Enrolled
Amir t Fathi, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

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

How many participants are involved in this research effort?

"Unfortunately, this clinical trial has suspended the recruitment of participants. It was first posted on July 17th 2018 and last updated on August 8th 2022. If you are seeking alternative medical studies related to cancer, there is a current pool of 3835 trials actively recruiting patients with cancer, as well as 24 Enasidenib-specific studies taking onboard new members."

Answered by AI

Is this clinical endeavor the inaugural iteration of its type?

"Enasidenib has been studied since 2013, when the drug was first sponsored by Celgene and scrutinized in a trial involving 345 participants. After being approved for Phase 1 & 2 trials, 24 distinct clinical studies are now taking place across 84 cities and 28 countries."

Answered by AI

What is the primary purpose of this clinical experiment?

"The primary outcome of this 28-day trial is to determine the Maximum Tolerable Dose (MTD). The number and severity of Enasidenib-related adverse events will be monitored based on Common Terminology Criteria for Adverse Events (CTCAE 4) standards. Additionally, researchers are looking into cumulative incidence of chronic GVHD, which is graded from mild to severe using an aggregate score system featuring 0 for no symptoms and 3 as the most serious signs. Lastly, a summary of mutations in the Isocitrate dehydrogenase gene via next-generation sequencing will also be evaluated."

Answered by AI

Has the FDA sanctioned Enasidenib for medicinal use?

"Due to the fact that this is a first phase trial, with limited evidence in support of efficacy and safety, Enasidenib was given a score of 1."

Answered by AI

Are there any openings remaining for participants of this clinical trial?

"Unfortunately, the clinical trial listed on clinicaltrials.gov is not presently recruiting candidates; although it was last updated as recently as August 8th 2022. However, 3859 other studies are currently welcoming participants."

Answered by AI

Has Enasidenib been the focus of any other research initiatives?

"Currently, 24 separate clinical trials focusing on Enasidenib are in progress. Of those studies, two have already reached Phase 3 testing. While Edmonton is a common site for these experimentations, there are over 600 other locations worldwide offering access to this medication trial."

Answered by AI
~3 spots leftby Apr 2025