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New treatment option for Myeloproliferative Neoplasms
Official title Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
ClinicalTrials.gov ID: NCT06291987
What this study is testing
What is Ivosidenib?
Ivosidenib is an investigational medicine, given as an once-daily, being studied as a potential treatment for myeloproliferative neoplasms.
Also referred to as TIBSOVO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Patients cannot be on concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol. Patients cannot have...
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active"...
- 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...
- 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...
- Pregnant women are excluded from this study because ruxolitinib and ivosidenib carry the potential for teratogenic or abortifacient effects. Because...
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.