---
title: Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
nct_id: NCT06181734
overall_status: COMPLETED
sponsor: iOMEDICO AG
study_type: OBSERVATIONAL
primary_condition: Acute Myeloid Leukemia (AML)
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06181734.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06181734"
ct_last_update_post_date: 2026-02-10
last_seen_at: "2026-05-12T06:35:42.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

**Official Title:** 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

**NCT ID:** [NCT06181734](https://clinicaltrials.gov/study/NCT06181734)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** iOMEDICO AG
- **Conditions:** Acute Myeloid Leukemia (AML)
- **Start Date:** 2023-12-20
- **Completion Date:** 2025-07-30
- **CT.gov Last Update:** 2026-02-10

## Brief 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Interventions

- **Ivosidenib** (DRUG) — inhibitor of mutant IDH1

## Primary Outcomes

- **Evaluate quality of life** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_ — Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time

## Secondary Outcomes

- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu** _(time frame: Baseline until end of study (during ivosidinib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Subjective well-being: Validation of EQ-5D-5L questionnaire** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assesment of effectiveness in routine treatment** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assesment of effectiveness in routine treatment** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assesment of effectiveness in routine treatment** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assesment of effectiveness in routine treatment** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assessment of drug safety** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Assessment of parameters of treatment decision making** _(time frame: From date of patient enrollment until start of treatment)_
- **Ivosidenib and azacitidine treatment: Dose intensity** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Ivosidenib and azacitidine treatment: Frequency and type of dose modification** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Ivosidenib and azacitidine treatment: Reason for dose modifications** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Ivosidenib and azacitidine treatment: Duration of treatment in total and for each substance** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Ivosidenib and azacitidine treatment: Reason for end of treatment (EOT)** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Transfusion dependency** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Concomitant medication** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Subsequent antineoplastic therapies** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Frequency of hospitalizations/emergency room visits** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Reasons for hospitalizations/emergency room visits** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_
- **Treatment reality in detail: Length of hospital stay** _(time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)_

## Locations (1)

- Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg im Breisgau, Germany

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.praxis für interdisziplinäre onkologie & hämatologie|freiburg im breisgau||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06181734.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06181734*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*