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

NCT06181734 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2026-02-10

No results posted yet for this study

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

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Ivosidenib

inhibitor of mutant IDH1

Sponsors & Collaborators

  • iOMEDICO AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181734 on ClinicalTrials.gov