Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
- Conditions
- Acute Myeloid Leukemia (AML)
- Registration Number
- NCT06181734
- Lead Sponsor
- iOMEDICO AG
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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Age 18 years or older.
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Newly diagnosed Acute Myeloid Leukemia (AML).
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Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation.
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Not eligible to receive standard induction chemotherapy.
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Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC.
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Signed written informed consent*
*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose
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For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language
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Other criteria according to current SmPC.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate quality of life Baseline until end of study (during invosidinib 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 Outcome Measures
Name Time Method Subjective well-being: Validation of FACT-Leu Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Time to deterioration of Trial Outcome Index
Treatment reality in detail: Transfusion dependency Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Proportion of transfusion dependent patients to independency and vice versa will be provided
Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Trial Outcome Index
Subjective well-being: Validation of EQ-5D-5L questionnaire Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Time to deterioration of the EQ-%D-5l visual analogue scale score over time
Assessment of parameters of treatment decision making 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.
Ivosidenib and azacitidine treatment: Reason for end of treatment (EOT) Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Frequency tables of EOT-reasons will be provided
Assesment of effectiveness in routine treatment Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Time to first response (TTR)
Assessment of drug safety Baseline until end of study (during invosidinib 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)
Ivosidenib and azacitidine treatment: Dose intensity Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Descriptive statistics will be provided for dose intensity for ivosidinib and azacitidine
Ivosidenib and azacitidine treatment: Frequency and type of dose modification Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Frequency tables will be provided for frequency and type of dose modification for ivosidinib and azacitidine
Ivosidenib and azacitidine treatment: Reason for dose modifications Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Frequency tables of reasons for dose modifications will be provided for ivosidinib and azacitidine
Ivosidenib and azacitidine treatment: Duration of treatment in total and for each substance Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Descriptive statistics will be provided for duration of treatment in total and for each substance dose
Treatment reality in detail: Concomitant medication Baseline until end of study (during invosidinib 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
Treatment reality in detail: Subsequent antineoplastic therapies Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Description of frequency and type of subsequent antineoplastic therapies by line of therapy (number and substance)
Treatment reality in detail: Frequency of hospitalizations/emergency room visits Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Frequency table of hospitalization and emergency room visits will be provided
Treatment reality in detail: Reasons for hospitalizations/emergency room visits Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Frequency table of reasons for hospitalization and emergency room visits will be provided
Treatment reality in detail: Length of hospital stay Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months Descriptive statistic for length of hospital stay will be provided
Trial Locations
- Locations (1)
Praxis für interdisziplinäre Onkologie & Hämatologie
🇩🇪Freiburg, Germany