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Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation (alloSCT) In Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Neoplasia (HR-MDS) with IDH1 Mutation (PIVOT)
EU CTIS ID: 2023-509055-14-00
What this study is testing
Main objective it to evaluate the efficacy of Ivosidenib (investigational drug) to improve event-free survival in patients with AML or MDS carrying an IDH1 mutation when given as 24 months maintenance therapy following allo SCT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Negative serum pregnancy test
- Male subjects must agree to refrain from unprotected sex and sperm donation from time point of signing the informed consent until 1 month after the last dose of the investigational medicinal product
- Willingness and ability to comply with all study procedures
- Informed consent signed by the patient capable of giving
- Eastern Cooperative Group (ECOG) performance status ≤
You likely can't join if
- Active acute GvHD grade III-IV according to Harris criteria requiring steroids > 1 mg/kg prednisolone equivalent
- Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject’s cooperation with the requirements of the trial or evaluation of the study results
- Significant cardiac disease: i.e., heart failure NYHA III or IV; unstable angina pectoris; recent myocardial infarction or clinically significant bradycardia
- Long QT syndrome (QTcF ≥480 msec on screening ECG)
- Concurrent use of medications that have a relative risk of prolonging QT interval or of inducing Torsade de Pointes unless it is secured that if patient receive medications with known QT interval prolonging potential concomitantly, ECG monitoring has to be conducted weekly, or more frequently based on institutional standards or investigator discretion for the first 3 weeks following initiation of Ivosidenib treatment
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Negative serum pregnancy test
- Male subjects must agree to refrain from unprotected sex and sperm donation from time point of signing the informed consent until 1 month after the last dose of the investigational medicinal product
- Willingness and ability to comply with all study procedures
- Informed consent signed by the patient capable of giving
- Eastern Cooperative Group (ECOG) performance status ≤
- AML or MDS according to WHO criteria with IDH1 mutation
- having received alloSCT within the past 100 days
- documented CR, CRi, CRh or MLFS after alloSCT within 28 days prior to enrolment (documented by bone marrow aspiration)
- Adequate organ function defined by: Serum creatinine clearance > 30 mL/min; calculated by the Cockcroft Gault formula
- Adequate organ function defined by: Serum total bilirubin ≤2 × ULN, unless considered to be due to Gilbert’s disease
- Adequate organ function defined by: Left ventricular ejection fraction (LVEF) ≥ 35%
What rules you out
- Active acute GvHD grade III-IV according to Harris criteria requiring steroids > 1 mg/kg prednisolone equivalent
- Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject’s cooperation with the requirements of the trial or evaluation of the study results
- Significant cardiac disease: i.e., heart failure NYHA III or IV; unstable angina pectoris; recent myocardial infarction or clinically significant bradycardia
- Long QT syndrome (QTcF ≥480 msec on screening ECG)
- Concurrent use of medications that have a relative risk of prolonging QT interval or of inducing Torsade de Pointes unless it is secured that if patient receive medications with known QT interval prolonging potential concomitantly, ECG monitoring has to be conducted weekly, or more frequently based on institutional standards or investigator discretion for the first 3 weeks following initiation of Ivosidenib treatment
- Pulmonary disease with clinically relevant hypoxia (need for oxygen inhalation)
- Patients undergoing renal dialysis
- Active severe or uncontrolled infection
- Any condition that limits the ingestion or gastrointestinal absorption of orally administered drugs
- Diagnosis of another primary malignancy that is currently clinically significant or currently requires active treatment / intervention
- Hypersensitivity known from medical history to Ivosidenib or its ingredients or to drugs with a similar chemical structure
- Concomitant administration of dabigatran and/or a familial history of sudden death or polymorphic ventricular arrhythmia and/or the rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Having received any unlicensed drug within 30 days or 5 half-lives, whichever is greater, prior to enrolment
- Addictions or other illnesses that do not allow the patient concerned to assess the nature and extent of the clinical trial and its possible consequences
- Pregnant or breastfeeding women, breastfeeding has to be discontinued before onset of treatment and until for at least 1 month after the last dose
- Patients who are unwilling to follow strictly highly effective contraception requirements including hormonal contraceptives with a Pearl Index < 1% per year in combination with a barrier method from time point of signing the informed consent until 1 month after the last dose of the IMP unless one of the following criteria is met: post-menopausal (12 months natural amenorrhoea or 6 months amenorrhoea with serum FSH > 40 U/ml)
- Patients who are unwilling to follow strictly highly effective contraception requirements including hormonal contraceptives with a Pearl Index < 1% per year in combination with a barrier method from time point of signing the informed consent until 1 month after the last dose of the IMP unless one of the following criteria is met: postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- Patients who are unwilling to follow strictly highly effective contraception requirements including hormonal contraceptives with a Pearl Index < 1% per year in combination with a barrier method from time point of signing the informed consent until 1 month after the last dose of the IMP unless one of the following criteria is met: medically confirmed ovarian failure
- Patients who are unwilling to follow strictly highly effective contraception requirements including hormonal contraceptives with a Pearl Index < 1% per year in combination with a barrier method from time point of signing the informed consent until 1 month after the last dose of the IMP unless one of the following criteria is met: vasectomy of the partner
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.