Acute Myeloid Leukemia (AML) Clinical Trial
— CONFIDHENCEOfficial 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
NCT number | NCT06181734 |
Other study ID # | iOM-070496 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2023 |
Est. completion date | June 30, 2028 |
Verified date | February 2024 |
Source | iOMEDICO AG |
Contact | iOMEDICO |
Phone | +49 761 152420 |
information[@]iomedico.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG |
Germany,
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 |
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