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 Type
OBSERVATIONAL
Enrollment
8
inhibitor of mutant IDH1
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Germany
Evaluate quality of life
Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time
Time frame: 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-Leu subscale score over time
Time frame: 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
Time frame: 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
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 to deterioration of FACT-Leu total score
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 to deterioration of FACT-G total score
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 to deterioration of Trial Outcome Index
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
FACT-Leu total score over time over time
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
FACT-G total score over time
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
Trial Outcome Index
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
Change from baseline of the EQ-5D-5L visual analogue scale score over time
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
EQ-5D-5L visual analogue scale score over time
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
Index value of EQ-5D-5L over time
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 to deterioration of the EQ-%D-5l visual analogue scale score over time
Time frame: 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),
Time frame: 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)
Time frame: 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))
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
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
Frequency tables will be provided for frequency and type of dose modification for ivosidinib and azacitidine
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
Frequency tables of reasons for dose modifications will be provided for ivosidinib and azacitidine
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
Descriptive statistics will be provided for duration of treatment in total and for each substance dose
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)
Frequency tables of EOT-reasons will be provided
Time frame: 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
Time frame: 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
Time frame: 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)
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
Frequency table of hospitalization and emergency room visits will be provided
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
Frequency table of reasons for hospitalization and emergency room visits will be provided
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
Descriptive statistic for length of hospital stay will be provided
Time frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months
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