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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Ruxolitinib — DRUG
  Patients who are on ruxolitinib will continue their current dose. Patients who are not on ruxolitinib will receive ruxolitinib dosing based on platelet count
• Enasidenib — DRUG
  50mg -100mg daily

Study Details

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.

Key Dates

Start date

Jan 14, 2021

Status verified

Jan 2025

Primary completion

May 30, 2023

Completion

May 30, 2023

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients with MPN
  Ruxolitinib and Enasidenib combination therapy

Primary Outcome Measure

Number of MPN Participants With Response [ Time Frame: 6 Months ]

Locations (10)

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