Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06291987
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ivosidenib — DRUG
    Ivosidenib will be given at assigned dose once daily.
  • Ruxolitinib — DRUG
    Ruxolitinib will be given at assigned dose twice daily.

Study Details

The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs.

Key Dates

Start date
Sep 19, 2024
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    Ivosidenib 500mg daily + Ruxolitinib 5mg twice a day
  • Experimental: Dose Level 1
    Ivosidenib 500mg daily + Ruxolitinib 10mg twice a day
  • Experimental: Dose Level 2
    Ivosidenib 500mg daily + Ruxolitinib 20mg twice a day

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Anand Patel (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

Related Studies