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IDH2 Inhibitor

Enasidenib for Chronic Myelomonocytic Leukemia

Phase 1 & 2

Recruiting

Led By Tian Yi Zhang, MD

Research Sponsored by Stanford University

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 12 months

Awards & highlights

Study Summary

This trial will test if a new drug, enasidenib, is safe and effective in people with lower risk myelodysplastic syndrome or nonproliferative chronic myelomonocytic leukemia. The drug will be given to people who do not have a mutation in isocitrate dehydrogenase type 2.

Who is the study for?

This trial is for adults with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML), without IDH2 mutation, who have anemia symptoms like fatigue and shortness of breath. Participants must not have had certain therapies recently, be able to take oral meds, and use effective contraception if applicable. They can't join if they have other causes of anemia, significant heart disease, less than 3 months life expectancy, active infections including HIV or hepatitis B/C.Check my eligibility

What is being tested?

The study tests whether enasidenib mesylate can safely improve anemia and reduce the need for blood transfusions in MDS/CMML patients without the IDH2 mutation. It's a phase 1b/2 trial where everyone gets increasing doses of enasidenib to see how well it works and what effects it has on their body.See study design

What are the potential side effects?

Possible side effects from enasidenib may include digestive issues such as nausea or vomiting, liver problems indicated by changes in blood tests, tiredness, decreased appetite or weight loss. Since this is a dose escalation study assessing safety too, close monitoring will occur to identify any new or unexpected side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Clinical Response: Hematological Improvement - Erythroid (HI-E)

Clinical Response: Hematological Improvement - Neutrophils (HI-N)

Clinical Response: Hematological Improvement - Platelets (HI-P)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Enasidenib mesylatExperimental Treatment1 Intervention

Participants will self administer the enasidenib orally everyday.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,572 Total Patients Enrolled

40 Trials studying Leukemia

11,841 Patients Enrolled for Leukemia

Tian Yi ZhangLead Sponsor

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,188 Total Patients Enrolled

82 Trials studying Leukemia

2,641 Patients Enrolled for Leukemia

Media Library

Enasidenib (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05282459 — Phase 1 & 2

Leukemia Research Study Groups: Enasidenib mesylat

Frequently Asked Questions

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

How many individuals are participating in this experiment?

"Affirmative. The clinicaltrials.gov site displays that this trial is currently accepting participants, with the initial posting occurring on December 1st 2022 and the last update taking place on May 12th of the same year. 48 patients are needed for enrolling from a single medical centre."

Answered by AI

Is enrollment open for this experiment?

"Affirmative. As per the clinicaltrials.gov records, this medical research project is actively enrolling participants and first went live on December 1st 2022. The trial aims to enrol 48 patients from a single clinic site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

Tian Yi Zhang 2022. "Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282459.

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