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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivosidenib | Drug | inhibitor of mutant IDH1 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate quality of life | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective well-being: Validation of FACT-Leu | 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 |
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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:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg im Breisgau | Germany |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000627630 | ivosidenib |
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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 | 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 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 to first response (TTR) | 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) | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |