Evaluating quality of life in patients with IDH1 R132-mutated AML treated with ivosidenib and azacitidine
Ivosidenib in Combination With Azacitidine as First-line Treatment for Adult Patients With Newly Diagnosed AML With an IDH1 R132 Mutation Who Are Not Eligible to Receive Standard Induction Chemotherapy
iOMEDICO AG · NCT06181734
This study is testing how a combination of two drugs, ivosidenib and azacitidine, affects the quality of life for adults with a specific type of leukemia who can't have standard chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Freiburg) |
| Trial ID | NCT06181734 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life in adult patients newly diagnosed with IDH1 R132-mutated acute myeloid leukemia (AML) who are not eligible for standard chemotherapy. Participants will receive treatment with ivosidenib in combination with azacitidine, and their quality of life will be evaluated using validated questionnaires during treatment and follow-up. The study will also assess treatment effectiveness, overall survival, event-free survival, and drug safety in a real-world setting in Germany.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with newly diagnosed IDH1 R132-mutated AML who cannot receive standard induction chemotherapy.
Not a fit: Patients who are not newly diagnosed or do not have the IDH1 R132 mutation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the quality of life and treatment outcomes for patients with a specific mutation in AML.
How similar studies have performed: While this study focuses on a specific mutation and treatment combination, similar studies have shown promise in evaluating quality of life and treatment outcomes in AML patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Freiburg
- Praxis für interdisziplinäre Onkologie & Hämatologie — Freiburg, Germany (RECRUITING)
Study contacts
- Study coordinator: iOMEDICO
- Email: information@iomedico.com
- Phone: +49 761 152420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, IDH1 R132 mutation