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Completed

NCT Number: NCT06181734

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

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

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ivosidenib

Drug

inhibitor of mutant IDH1

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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),

  15. 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)

  16. 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))

  17. 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)

  18. 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)

  19. 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.

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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)

  28. 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

  29. 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

  30. 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

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study 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

Acronym: CONFIDHENCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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