Clinical trial · Observational
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivosidenib | Drug | Ivosidenib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate quality of life
- timeFrame
- Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
- description
- Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time
Secondary outcomes (30)
- measure
- Subjective well-being: Validation of FACT-Leu
- timeFrame
- Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
- description
- Change from baseline (treatment start) of FACT-Leu subscale score over time
- measure
- Subjective well-being: Validation of FACT-Leu
- timeFrame
- Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
- description
- Change from baseline (treatment start) of FACT-G total scores over time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available