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

NCT06181734 | Completed

• 1 other identifier: iOM-070496
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia (AML)

Keywords

IDH1 R132 mutation

Outcome Measures

Primary Outcomes (1)

• Evaluate quality of life

  Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time

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

Secondary Outcomes (30)

• Subjective well-being: Validation of FACT-Leu

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

• Subjective well-being: Validation of FACT-Leu

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

• Subjective well-being: Validation of FACT-Leu

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

• Subjective well-being: Validation of FACT-Leu

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

• Subjective well-being: Validation of FACT-Leu

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

Interventions

Ivosidenib DRUG

inhibitor of mutant IDH1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed, IDH1 R132- mutated AML who are not eligible to receive standard induction chemotherapy and with treatment decision for ivosidenib in combination with azacitidine according to SmPC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

ivosidenib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 26, 2023
• Study Start: December 20, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)