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IDH2 Inhibitor

Enasidenib for Clonal Cytopenia

Phase 2

Waitlist Available

Led By Kelly Bolton, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Presence of IDH2 gene mutation (R140 or R172) at a frequency ≥ 2%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment through completion of follow-up (up to approximately 18 months)

Awards & highlights

Study Summary

This trial is investigating whether a drug called enasidenib can help improve blood cell counts in people with clonal cytopenia of undetermined significance (CCUS) by blocking a mutated protein.

Who is the study for?

This trial is for individuals with clonal cytopenia of undetermined significance (CCUS), which includes conditions like anemia, low white blood cell count, and low platelet count. Participants should have mutations in the IDH2 gene.Check my eligibility

What is being tested?

The study is testing enasidenib, a drug that targets the mutated IDH2 protein. The goal is to see if it can safely and effectively improve blood cell counts in people with CCUS.See study design

What are the potential side effects?

Potential side effects of enasidenib may include but are not limited to nausea, vomiting, diarrhea, elevated levels of bilirubin in the blood (jaundice), and differentiation syndrome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer has a specific IDH2 gene mutation.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through completion of follow-up (up to approximately 18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through completion of follow-up (up to approximately 18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through completion of follow-up (up to approximately 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 hematologic response

Secondary outcome measures

Acute myeloid leukemia (AML-free) or myelodysplastic syndrome (MDS)-free survival

Change in mutant IDH2 variant allele fraction

Toxicity as measured by the number of adverse events experienced by participant

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%

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

Participants will receive enasidenib 100 mg daily for 18 cycles (each cycle is 28 days). Participants will continue treatment with enasidenib until confirmed progression to AML or MDS, development of unacceptable toxicity, or suspicion of disease progression, provided the patient is deriving clinical benefit, which will be determined at the discretion of the principal investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enasidenib

2020

Completed Phase 2

~560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,049 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,680 Total Patients Enrolled

Damon Runyon Cancer Research FoundationOTHER

9 Previous Clinical Trials

1,339 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for participants in this research study?

"According to clinicaltrials.gov, the current status of this research study does not involve participant recruitment. The trial was first listed on 4/30/2024 and last updated on 1/26/2024. Although this specific trial is inactive in terms of enrollment, there are a total of 340 active studies seeking participants as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

2024. "Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06240754.

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