Myeloproliferative NeoplasmsPhase 1MPNNCT06291987
Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
A Phase 1 study testing Ivosidenib and Ruxolitinib in people with Myeloproliferative Neoplasms, run by University of Chicago at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Neoplasms
- What is being tested?
- Ivosidenib and Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2024to May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed/refractory) including any of the following:
- polycythemia vera with (PV) ≥ 5% peripheral or bone marrow blasts at time of screening
- essential thrombocythemia (ET) with ≥ 5% peripheral or bone marrow blasts at time of screening
- primary myelofibrosis (PMF) with ≥ 5% peripheral or bone marrow blasts at time of screening
- Atypical CML with ≥ 5% peripheral or bone marrow blasts at time of screening
- MPN-NOS with ≥ 5% peripheral or bone marrow blasts at time of screening
Show all 23Show fewer
- MDS/MPN Overlap Syndromes including CMML with ≥ 5% peripheral or bone marrow blasts at time of screening
- post-PV myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening
- post-ET myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening
- primary and secondary myelofibrosis with inadequate response to JAK inhibitor regardless of blast percentage. Inadequate response to JAK inhibitor will be defined as lack of achieving any clinical improvement criteria within 12 weeks of of JAK inhibitor initiation.
- Patients can be on cytoreduction at time of study enrollment with hydroxyurea or steroids.
- Age ≥18 years.
- ECOG performance status ≤2
- Patients must have normal organ and marrow function as defined below:
- Creatinine clearance ≥60 mL/min, determined by the Cockroft-Gault formula, OR serum creatinine ≤ 1.5 x ULN
- AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome, leukemic involvement, or extravascular hemolysis in the spleen)
- A platelet count of 50 x 109/L should be met for those with chronic-phase myelofibrosis and < 5% blasts peripherally or in bone marrow
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Other eligibility criteria include the following:
- Patients must be at least 4 weeks from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.
- The effects of the investigational agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients cannot be on concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol. Patients cannot have had prior treatment with ivosidenib.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease or they are not currently requiring treatment for an indolent malignancy. Patients with APL and active CNS disease would also be excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivosidenib or ruxolitinib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, venous thromboembolism, stroke, active chronic liver disease (eg chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cholangitis, hemochromatosis) or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject has QTc interval ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events at screening unless due to bundle branch block or pacemaker with approval of the principal investigator.
- Pregnant women are excluded from this study because ruxolitinib and ivosidenib carry the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib and ivosidenib, breastfeeding should be discontinued if the mother is treated with any of these agents.
- Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 should have eligibility and alternative medications reviewed by site PI.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Anand Patel
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kristin Komnick, 414-805-6402, kkomnick@mcw.edu
About this study
Official title: A Phase 1b Trial of Ivosidenib Combined With Ruxolitinib in IDH1-Mutated Advanced-Phase MPNs
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
- Myeloproliferative Neoplasms
- Being tested
- Ivosidenib, Ruxolitinib
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvosidenibDrug
Also called TIBSOVO
Ivosidenib will be given at assigned dose once daily.
RuxolitinibDrug
Also called Jakafi
Ruxolitinib will be given at assigned dose twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level -1 | Experimental | Ivosidenib 500mg daily + Ruxolitinib 5mg twice a day Receives: Drug: Ivosidenib; Drug: Ruxolitinib |
| Dose Level 1 | Experimental | Ivosidenib 500mg daily + Ruxolitinib 10mg twice a day Receives: Drug: Ivosidenib; Drug: Ruxolitinib |
| Dose Level 2 | Experimental | Ivosidenib 500mg daily + Ruxolitinib 20mg twice a day Receives: Drug: Ivosidenib; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (5)
Overall Survival (OS)
Percentage of participants still alive after 5 years.
Measured: 5 years
Overall Response Rate (ORR)
Percentage of participants that meet protocol defined criteria for response to study treatments.
Measured: 5 years
Time to Response (TTR)
Time from treatment administration to first documented response.
Measured: 5 years
Duration of response (DOR)
Time from achieving a response until disease progression, relapse, or death.
Measured: 5 years
Progression free survival (PFS)
Time from treatment administration until disease progression, relapse, or death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start19 Sep 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Patel, Principal investigator, University of Chicago Medicine Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291987
- Sponsor's protocol ID
- IRB23-1681
- Acronym
- MPN
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of Ivosidenib Combined With Ruxolitinib in IDH1-Mutated Advanced-Phase MPNs
- ClinicalTrials.gov ID
- NCT06291987
- Acronym / sponsor ID
- MPN / IRB23-1681
- Conditions
- Myeloproliferative Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level -1 | Experimental | Drug: Ivosidenib, Drug: RuxolitinibIvosidenib 500mg daily + Ruxolitinib 5mg twice a day |
| Dose Level 1 | Experimental | Drug: Ivosidenib, Drug: RuxolitinibIvosidenib 500mg daily + Ruxolitinib 10mg twice a day |
| Dose Level 2 | Experimental | Drug: Ivosidenib, Drug: RuxolitinibIvosidenib 500mg daily + Ruxolitinib 20mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed/refractory) including any of the following:
- Patients can be on cytoreduction at time of study enrollment with hydroxyurea or steroids.
- Age ≥18 years.
- ECOG performance status ≤2
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (8 listed)
- Patients cannot be on concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol. Patients cannot have had prior treatment with ivosidenib.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease or they are not currently requiring treatment for an indolent malignancy. Patients with APL and active CNS disease would also be excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivosidenib or ruxolitinib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, venous thromboembolism, stroke, active chronic liver disease (eg chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cholangitis, hemochromatosis) or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject has QTc interval ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events at screening unless due to bundle branch block or pacemaker with approval of the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvosidenibAlso: TIBSOVOIvosidenib will be given at assigned dose once daily. | Drug | Dose Level -1, Dose Level 1, Dose Level 2 |
| RuxolitinibAlso: JakafiRuxolitinib will be given at assigned dose twice daily. | Drug | Dose Level -1, Dose Level 1, Dose Level 2 |
Primary outcome
Maximum tolerated dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The highest dose of a drug or treatment that does not cause unacceptable side effects.
5 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Overall Response Rate (ORR)
Time frame: 5 years
Time to Response (TTR)
Time frame: 5 years
Duration of response (DOR)
Time frame: 5 years
Progression free survival (PFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Patel principal investigator
University of Chicago Medicine Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivosidenib and Ruxolitinib in people with Myeloproliferative Neoplasms, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.