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

February 6, 2026 updated by: iOMEDICO AG

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of parameters of treatment decision making
Time Frame: From date of patient enrollment until start of treatment
Frequency of distinct parameters affecting therapy choice including reasons why patient is ineligible for standard induction chemotherapy.
From date of patient enrollment until start of treatment
Subjective well-being: Validation of FACT-Leu
Time Frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Change from baseline (treatment start) of FACT-Leu subscale score over time
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
Change from baseline (treatment start) of FACT-G total scores over time
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
Change from baseline (treatment start) of Trial outcome Index over time
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
Time to deterioration of FACT-Leu total score
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
Time to deterioration of FACT-G total score
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
Time to deterioration of Trial Outcome Index
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
FACT-Leu total score over time over time
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
FACT-G total score over time
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
Trial Outcome Index
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
Change from baseline of the EQ-5D-5L visual analogue scale score over time
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
EQ-5D-5L visual analogue scale score over time
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
Index value of EQ-5D-5L over time
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
Time to deterioration of the EQ-%D-5l visual analogue scale score over time
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 overall survival (OS),
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
Event-free survival (EFS)
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
Overall Response Rate (ORR; i.e. CR, CR with incomplete hematologic recovery (Cri), (including CR with incomplete platelet recovery (CRp), CR with partial hematologic recovery (CRh), or partial recovery (PR)), Duration of CR (DOCR), Duration of Response (DOR; CR, Cri, CRp, CRh, PR))
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
Time to first response (TTR)
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
Assesment of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), Adverse events of special interest (AESIs)
Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Ivosidenib and azacitidine treatment: Dose intensity
Time Frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Descriptive statistics will be provided for dose intensity for ivosidinib and azacitidine
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
Frequency tables will be provided for frequency and type of dose modification for ivosidinib and azacitidine
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
Frequency tables of reasons for dose modifications will be provided for ivosidinib and azacitidine
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
Descriptive statistics will be provided for duration of treatment in total and for each substance dose
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
Frequency tables of EOT-reasons will be provided
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
Proportion of transfusion dependent patients to independency and vice versa will be provided
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
Frequency table of concomitant medication in total and frequency of concomitant medications known to induce QT prolongation (e.g., antiarrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) as well as strong CYP3A4 inducers or dabigatran will be provided
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
Description of frequency and type of subsequent antineoplastic therapies by line of therapy (number and substance)
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
Frequency table of hospitalization and emergency room visits will be provided
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
Frequency table of reasons for hospitalization and emergency room visits will be provided
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
Descriptive statistic for length of hospital stay will be provided
Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iOMEDICO AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • iOM-070496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia (AML)

Clinical Trials on Ivosidenib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings