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IDH2 Inhibitor

Enasidenib for Clonal Cytopenia

Phase 1
Recruiting
Led By Eytan Stein, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 up to 18 months
Awards & highlights

Study Summary

This trial is testing whether a drug called enasidenib can improve blood cell counts in people with clonal cytopenia of undetermined significance (CCUS).

Who is the study for?
Adults over 18 with clonal cytopenia of undetermined significance (CCUS) and IDH2 gene mutation can join this trial. They must have had unexplained low blood counts for at least 6 months, be in fair health, and able to follow the study plan. Pregnant women or those with active cancer, recent malignancy history, certain infections or conditions affecting drug absorption cannot participate.Check my eligibility
What is being tested?
The trial is testing Enasidenib's safety and effectiveness on CCUS by blocking a mutated protein that may improve blood cell counts. Participants will take Enasidenib orally to see if it helps increase their white blood cells, platelets, and hemoglobin levels.See study design
What are the potential side effects?
Enasidenib might cause side effects like jaundice due to high bilirubin levels in some cases; however specific side effects are not listed here but generally could include digestive issues, liver enzyme changes, fatigue or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Response

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%
Arthralgia
14%
Alanine aminotransferase increased
14%
Bacteraemia
14%
Wound complication
14%
Lung infection
14%
Dehydration
14%
Herpes simplex
14%
Hypomagnesaemia
14%
Syncope
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: Participants with CCUS with mutations in IDH2Experimental Treatment1 Intervention
Participants will have CCUS with mutations in IDH2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enasidenib
2020
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,942 Previous Clinical Trials
588,983 Total Patients Enrolled
Eytan Stein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Enasidenib (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05102370 — Phase 1
Clonal Cytopenia Research Study Groups: Participants with CCUS with mutations in IDH2
Clonal Cytopenia Clinical Trial 2023: Enasidenib Highlights & Side Effects. Trial Name: NCT05102370 — Phase 1
Enasidenib (IDH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05102370 — Phase 1
~5 spots leftby Oct 2025
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