Clinical trial NCT06181734: Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
Keywords: IDH1 R132 mutation
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate quality of life
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary outcomes:
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Subjective well-being: Validation of EQ-5D-5L questionnaire
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assesment of effectiveness in routine treatment
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assesment of effectiveness in routine treatment
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assesment of effectiveness in routine treatment
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assesment of effectiveness in routine treatment
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assessment of drug safety
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Assessment of parameters of treatment decision making
timeFrame: From date of patient enrollment until start of treatment
measure: Ivosidenib and azacitidine treatment: Dose intensity
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Ivosidenib and azacitidine treatment: Frequency and type of dose modification
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Ivosidenib and azacitidine treatment: Reason for dose modifications
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Ivosidenib and azacitidine treatment: Duration of treatment in total and for each substance
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Ivosidenib and azacitidine treatment: Reason for end of treatment (EOT)
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Transfusion dependency
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Concomitant medication
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Subsequent antineoplastic therapies
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Frequency of hospitalizations/emergency room visits
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Reasons for hospitalizations/emergency room visits
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
measure: Treatment reality in detail: Length of hospital stay
timeFrame: Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie
Study officials:
References: