Acute Myeloid Leukemia (AML)CONFIDHENCENCT06181734
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
An observational study of Acute Myeloid Leukemia (AML), run by iOMEDICO AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Ivosidenib
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 20 Dec 2023to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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*
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau
About this study
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
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)
- Being tested
- Ivosidenib
- Keywords
- IDH1 R132 mutation
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvosidenibDrug
inhibitor of mutant IDH1
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate quality of life
Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time
Measured: 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
Change from baseline (treatment start) of FACT-Leu subscale score over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of FACT-Leu
Change from baseline (treatment start) of FACT-G total scores over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of FACT-Leu
Change from baseline (treatment start) of Trial outcome Index over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of FACT-Leu
Time to deterioration of FACT-Leu total score
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of FACT-Leu
Time to deterioration of FACT-G total score
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of FACT-Leu
Time to deterioration of Trial Outcome Index
Measured: 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
FACT-Leu total score over time over time
Measured: 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
FACT-G total score over time
Measured: 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
Trial Outcome Index
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of EQ-5D-5L questionnaire
Change from baseline of the EQ-5D-5L visual analogue scale score over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of EQ-5D-5L questionnaire
EQ-5D-5L visual analogue scale score over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Subjective well-being: Validation of EQ-5D-5L questionnaire
Index value of EQ-5D-5L over time
Measured: 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 to deterioration of the EQ-%D-5l visual analogue scale score over time
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assesment of effectiveness in routine treatment
Assesment of overall survival (OS),
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assesment of effectiveness in routine treatment
Event-free survival (EFS)
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assesment of effectiveness in routine treatment
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))
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assesment of effectiveness in routine treatment
Time to first response (TTR)
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assessment of drug safety
Assesment of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), Adverse events of special interest (AESIs)
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Assessment of parameters of treatment decision making
Frequency of distinct parameters affecting therapy choice including reasons why patient is ineligible for standard induction chemotherapy.
Measured: From date of patient enrollment until start of treatment
Ivosidenib and azacitidine treatment: Dose intensity
Descriptive statistics will be provided for dose intensity for ivosidinib and azacitidine
Measured: 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
Frequency tables will be provided for frequency and type of dose modification for ivosidinib and azacitidine
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Ivosidenib and azacitidine treatment: Reason for dose modifications
Frequency tables of reasons for dose modifications will be provided for ivosidinib and azacitidine
Measured: 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
Descriptive statistics will be provided for duration of treatment in total and for each substance dose
Measured: 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)
Frequency tables of EOT-reasons will be provided
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Treatment reality in detail: Transfusion dependency
Proportion of transfusion dependent patients to independency and vice versa will be provided
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Treatment reality in detail: Concomitant medication
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
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Treatment reality in detail: Subsequent antineoplastic therapies
Description of frequency and type of subsequent antineoplastic therapies by line of therapy (number and substance)
Measured: 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
Frequency table of hospitalization and emergency room visits will be provided
Measured: 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
Frequency table of reasons for hospitalization and emergency room visits will be provided
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Treatment reality in detail: Length of hospital stay
Descriptive statistic for length of hospital stay will be provided
Measured: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start20 Dec 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181734
- Sponsor's protocol ID
- iOM-070496
- Acronym
- CONFIDHENCE
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06181734
- Acronym / sponsor ID
- CONFIDHENCE / iOM-070496
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- IDH1 R132 mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivosidenibinhibitor of mutant IDH1 | Drug | – |
Primary outcome
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
30 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate quality of life (time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.