CompletedNot Applicable

Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

Germany8 participantsStarted 2023-12-20

Plain-language summary

The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany. The main questions it aims to answer are: * Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire and European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire during treatment and follow-up period * Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate) * Assessment of drug safety (all adverse events) * Description of treatment reality in detail

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older. * Newly diagnosed Acute Myeloid Leukemia (AML). * Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation. * Not eligible to receive standard induction chemotherapy. * Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC. * Signed written informed consent\* \*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose * For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language * Other criteria according to current SmPC. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period. * Patients unable to consent * Other contraindications according to current SmPC.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate quality of life

Timeframe: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months

Trial details

NCT IDNCT06181734

SponsoriOMEDICO AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Acute Myeloid Leukemia (AML) trials