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

Acute Myeloid Leukemia (AML) Clinical Trial

— CONFIDHENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181734
• Other study ID #: iOM-070496
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: February 2024
• Source: iOMEDICO AG
• Contact: iOMEDICO
• Phone: +49 761 152420
• Email: information[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 before start of study treatment.
• 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Ivosidenib
inhibitor of mutant IDH1

Locations

Country	Name	City	State
Germany	Praxis für interdisziplinäre Onkologie & Hämatologie	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate quality of life	Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of FACT-Leu	Change from baseline (treatment start) of FACT_Leu subscale score	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of FACT-Leu	Time to deterioration of FACT-Leu total score	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire	Change from baseline and TTD of FACT-G total score	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire	Trial Outcome Index	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of EQ-5D-5L questionnaire	Change from baseline of the EQ-5D-5L visual analogue scale (VAS)	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Subjective well-being: Validation of EQ-5D-5L questionnaire	Index value of EQ-5D-5L over time	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Assesment of effectiveness in routine treatment	Assesment of overall survival (OS),	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Assesment of effectiveness in routine treatment	Event-free survival (EFS)	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Assesment of effectiveness in routine treatment	Time to first response (TTR)	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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
Secondary	Ivosidenib and azacitidine treatment: Dose intensity	Descriptive statistics will be provided for dose intensity for ivosidinib and azacitidine	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Ivosidenib and azacitidine treatment: Frequency and type of dose modification	Frequency tabels will be provided for frequency and type of dose modification for ivosidinib and azacitidine	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Ivosidenib and azacitidine treatment: Reason for dose modifications	Frequeny tabels of reasons for dose modifications will be provided for ivosidinib and azacitidine	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 substancedose	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Ivosidenib and azacitidine treatment: Reason for end of treatment (EOT)	Frequency tabels of EOT-reasons will be provided	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 invosidinib treatment and Follow-Up); Up to 54 months
Secondary	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 invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Treatment reality in detail: Frequency of hospitalizations/emergency room visits	Frequency tabel of hospitalization and emergency room visits will be provided	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Treatment reality in detail: Reasons for hospitalizations/emergency room visits	Frequency tabel of reasons for hospitalization and emergency room visits will be provided	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months
Secondary	Treatment reality in detail: Length of hospital stay	Descriptive statistic for length of hospital stay will be privided	Baseline until end of study (during invosidinib treatment and Follow-Up); Up to 54 months