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Clinical Trials/NCT06181734
NCT06181734CompletedNot Applicable

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

iOMEDICO AG1 site in 1 country8 target enrollmentStarted: December 20, 2023Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Locations
1
Primary Endpoint
Evaluate quality of life
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Evaluate quality of life

Time Frame: Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months

Validation of FACT-Leu. Change from baseline (treatment start) of FACT-Leu total score over time

Secondary Outcomes

  • Subjective well-being: Validation of FACT-Leu and EQ-5D-5L questionnaire(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Subjective well-being: Validation of EQ-5D-5L questionnaire(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Assesment of effectiveness in routine treatment(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Subjective well-being: Validation of FACT-Leu(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Subjective well-being: Validation of FACT-Leu(Baseline until end of study (during ivosidinib treatment and Follow-Up); Up to 54 months)
  • Assessment of drug safety(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Assessment of parameters of treatment decision making(From date of patient enrollment until start of treatment)
  • Ivosidenib and azacitidine treatment: Dose intensity(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(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Ivosidenib and azacitidine treatment: Reason for dose modifications(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(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)(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Treatment reality in detail: Transfusion dependency(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Treatment reality in detail: Concomitant medication(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Treatment reality in detail: Subsequent antineoplastic therapies(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(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(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)
  • Treatment reality in detail: Length of hospital stay(Baseline until end of study (during ivosidenib treatment and Follow-Up); Up to 54 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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