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Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

NCT04281498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-02-04

Study results available
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Summary

The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.

Conditions

  • Accelerated/Blast-phase Myeloproliferative Neoplasm
  • Chronic-phase Myelofibrosis
  • IDH2 Mutation

Interventions

DRUG

Ruxolitinib

Patients who are on ruxolitinib will continue their current dose. Patients who are not on ruxolitinib will receive ruxolitinib dosing based on platelet count

DRUG

Enasidenib

50mg -100mg daily

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Incyte Corporation

    collaborator INDUSTRY

  • Myeloproliferative Neoplasms Research Consortium

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

  • Ruben Mesa, MD · Mays Cancer Center at UT Health

  • Ronald Hoffman, MD · Icahn School of Medicine at Mount Sinai

  • Michal Bar-Natan, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2023-05-30
Completion
2023-05-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT04281498 on ClinicalTrials.gov