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

NCT05282459 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-17

Study results available
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Summary

This is a phase 1b/2, open-label, single arm study to evaluate if enasidenib is safe and effective in improving anemia and decreasing transfusion needs in subjects diagnosed with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) without a mutation in isocitrate dehydrogenase type 2 (IDH2 wildtype). Other objectives include assessment of improvements in platelet production and characterization of the mechanism of action of enasidenib in enhancing endogenous erythropoiesis.

Conditions

  • Leukemia
  • Leukemia, Myeloid
  • Monocytic Leukemia

Interventions

DRUG

Enasidenib mesylat dose escalation

Subjects will participate dose escalation with a starting dose of 100 mg. Enasidenib will be self administered orally and daily.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Tian Yi Zhang

    lead OTHER

Principal Investigators

  • Tian Yi Zhang, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2024-12-03
Completion
2025-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282459 on ClinicalTrials.gov