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IDH2 Inhibitor

Enasidenib for Clonal Cytopenia

Phase 1
Waitlist Available
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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best Response

Side effects data

From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739
67%
Asthenia
67%
Decreased appetite
67%
Cough
67%
Dyspnoea
33%
Dysphagia
33%
Pyrexia
33%
Hyperglycaemia
33%
Musculoskeletal chest pain
33%
Tachypnoea
33%
Sinus tachycardia
33%
Hypoalbuminaemia
33%
Partial seizures
33%
Disease progression
33%
Sepsis
33%
Dehydration
33%
Mental status changes
33%
Pneumonia aspiration
33%
Anaemia
33%
Supraventricular tachycardia
33%
Constipation
33%
Nausea
33%
Fatigue
33%
Oedema peripheral
33%
Skin bacterial infection
33%
Fall
33%
Shunt malfunction
33%
Blood alkaline phosphatase increased
33%
Blood lactate dehydrogenase increased
33%
Lipase decreased
33%
Costochondritis
33%
Musculoskeletal pain
33%
Osteonecrosis
33%
Dizziness
33%
Dysuria
33%
Dyspnoea exertional
33%
Acne
33%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enasidenib 100 mg
Enasidenib 200 mg
Enasidenib 400 mg
Enasidenib 650 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,496 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
~1 spots leftby Oct 2025
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