Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 7:02 AM
Study NCT ID:
NCT06181734
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627630', 'term': 'ivosidenib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate quality of life', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time'}], 'secondaryOutcomes': [{'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Change from baseline (treatment start) of FACT-Leu subscale score over time'}, {'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Change from baseline (treatment start) of FACT-G total scores over time'}, {'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Change from baseline (treatment start) of Trial outcome Index over time'}, {'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Time to deterioration of FACT-Leu total score'}, {'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Time to deterioration of FACT-G total score'}, {'measure': 'Subjective well-being: Validation of FACT-Leu', 'timeFrame': 'Baseline until end of study (during ivosidinib treatment and Follow-Up); Up to 54 months', 'description': 'Time to deterioration of Trial Outcome Index'}, {'measure': 'Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'FACT-Leu total score over time over time'}, {'measure': 'Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'FACT-G total score over time'}, {'measure': 'Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Trial Outcome Index'}, {'measure': 'Subjective well-being: Validation of EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Change from baseline of the EQ-5D-5L visual analogue scale score over time'}, {'measure': 'Subjective well-being: Validation of EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'EQ-5D-5L visual analogue scale score over time'}, {'measure': 'Subjective well-being: Validation of EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Index value of EQ-5D-5L over time'}, {'measure': 'Subjective well-being: Validation of EQ-5D-5L questionnaire', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Time to deterioration of the EQ-%D-5l visual analogue scale score over time'}, {'measure': 'Assesment of effectiveness in routine treatment', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Assesment of overall survival (OS),'}, {'measure': 'Assesment of effectiveness in routine treatment', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Event-free survival (EFS)'}, {'measure': 'Assesment of effectiveness in routine treatment', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': '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))'}, {'measure': 'Assesment of effectiveness in routine treatment', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Time to first response (TTR)'}, {'measure': 'Assessment of drug safety', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Assesment of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), Adverse events of special interest (AESIs)'}, {'measure': 'Assessment of parameters of treatment decision making', 'timeFrame': 'From date of patient enrollment until start of treatment', 'description': 'Frequency of distinct parameters affecting therapy choice including reasons why patient is ineligible for standard induction chemotherapy.'}, {'measure': 'Ivosidenib and azacitidine treatment: Dose intensity', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Descriptive statistics will be provided for dose intensity for ivosidinib and azacitidine'}, {'measure': 'Ivosidenib and azacitidine treatment: Frequency and type of dose modification', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Frequency tables will be provided for frequency and type of dose modification for ivosidinib and azacitidine'}, {'measure': 'Ivosidenib and azacitidine treatment: Reason for dose modifications', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Frequency tables of reasons for dose modifications will be provided for ivosidinib and azacitidine'}, {'measure': 'Ivosidenib and azacitidine treatment: Duration of treatment in total and for each substance', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Descriptive statistics will be provided for duration of treatment in total and for each substance dose'}, {'measure': 'Ivosidenib and azacitidine treatment: Reason for end of treatment (EOT)', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Frequency tables of EOT-reasons will be provided'}, {'measure': 'Treatment reality in detail: Transfusion dependency', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Proportion of transfusion dependent patients to independency and vice versa will be provided'}, {'measure': 'Treatment reality in detail: Concomitant medication', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': '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'}, {'measure': 'Treatment reality in detail: Subsequent antineoplastic therapies', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Description of frequency and type of subsequent antineoplastic therapies by line of therapy (number and substance)'}, {'measure': 'Treatment reality in detail: Frequency of hospitalizations/emergency room visits', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Frequency table of hospitalization and emergency room visits will be provided'}, {'measure': 'Treatment reality in detail: Reasons for hospitalizations/emergency room visits', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Frequency table of reasons for hospitalization and emergency room visits will be provided'}, {'measure': 'Treatment reality in detail: Length of hospital stay', 'timeFrame': 'Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months', 'description': 'Descriptive statistic for length of hospital stay will be provided'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IDH1 R132 mutation'], 'conditions': ['Acute Myeloid Leukemia (AML)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* 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\n* Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate)\n* Assessment of drug safety (all adverse events)\n* Description of treatment reality in detail'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Newly diagnosed Acute Myeloid Leukemia (AML).\n* Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation.\n* Not eligible to receive standard induction chemotherapy.\n* Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC.\n* Signed written informed consent\\*\n\n \\*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose\n* For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language\n* Other criteria according to current SmPC.\n\nExclusion Criteria:\n\n* 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.\n* Patients unable to consent\n* Other contraindications according to current SmPC.'}, 'identificationModule': {'nctId': 'NCT06181734', 'acronym': 'CONFIDHENCE', 'briefTitle': 'Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'iOM-070496'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ivosidenib', 'type': 'DRUG', 'description': 'inhibitor of mutant IDH1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Praxis für interdisziplinäre Onkologie & Hämatologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}