Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT06291987

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

Led by University of Chicago · Updated on 2025-11-05

18

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced-phase IDH1-mutated Philadelphia chromosome-negative myeloproliferative neoplasms including polycythemia vera, essential thrombocythemia, primary myelofibrosis, atypical chronic myeloid leukemia, MPN-not otherwise specified, MDS/MPN overlap syndromes including CMML, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis with 5% or more peripheral or bone marrow blasts at screening
  • Primary and secondary myelofibrosis with inadequate response to JAK inhibitor defined as no clinical improvement within 12 weeks of starting JAK inhibitor
  • Patients may be on hydroxyurea or steroids at enrollment
  • Age 18 years or older
  • ECOG performance status 2 or less
  • Normal organ and marrow function including creatinine clearance of 60 mL/min or higher or serum creatinine ≤ 1.5 times upper limit of normal
  • AST and ALT ≤ 3 times upper limit of normal and bilirubin ≤ 1.5 times upper limit of normal unless due to Gilbert's syndrome, leukemic involvement, or extravascular hemolysis
  • Platelet count of 50 x 10^9/L or higher for chronic-phase myelofibrosis with less than 5% blasts
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
  • Patients with chronic hepatitis B virus infection must have undetectable viral load on suppressive therapy if indicated
  • Patients with hepatitis C virus infection must be cured or have undetectable viral load if currently on treatment
  • At least 4 weeks since major surgery, radiation therapy, or participation in other investigational trials with recovery from significant toxicities
  • Women of child-bearing potential and men must agree to use adequate contraception during study participation
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with ivosidenib
  • Concomitant chemotherapy, radiation therapy, or immunotherapy not specified in the protocol
  • Active second malignancy other than non-melanoma skin cancer, except if therapy completed and disease-free or indolent malignancy not requiring treatment; active acute promyelocytic leukemia or CNS disease
  • History of allergic reactions to ivosidenib, ruxolitinib, or similar compounds
  • Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, venous thromboembolism, stroke, active chronic liver disease, or psychiatric/social conditions limiting study compliance
  • QTc interval ≥ 450 msec or other risk factors for QT prolongation unless due to bundle branch block or pacemaker with investigator approval
  • Pregnant or breastfeeding women
  • Known difficulty swallowing, short-gut syndrome, gastroparesis, or other conditions limiting oral drug absorption
  • Use of medications or substances that inhibit or induce CYP3A4 without review and approval by study site principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

C

Clinical Trials Intake

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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