NCT06181734已完成不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Evaluate quality of life
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate quality of life
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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