An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
1. Number of Adverse Events (AEs) (Time Frame - up to week 116): Adverse events (AEs) will be graded according to the CTCAE v5.0
2. Number of Serious Adverse Events (SAEs) (Time Frame - up to week 116): Adverse events (AEs) will be graded according to the CTCAE v5.0
3. Differentiation Syndrome of Grade 2 or higher (Time Frame - up to week 116)
4. Number of Adverse Events (AEs) leading to ivosidenib + azacitidine discontinuation (Time Frame - up to week 112)
5. Number of Adverse Events (AEs) leading to ivosidenib + azacitidine interruption (Time Frame - up to week 112)
6. Number of Adverse Events (AEs) leading to ivosidenib + azacitidine dose reduction (Time Frame - up to week 112)
7. Number of Adverse Events (AEs) leading to death (Time Frame - up to week 116)
8. Number of clinical laboratory anomalies assessed as Adverse Events (AEs) (Time Frame - up to week 116)
9. Number of patients requiring transfusion (platelet and RBC) and the average number of units transfused (Time Frame - up to week 116)
10. Rate of infections (Time Frame - up to week 116): Infection rates will be summarized by classification and will include a count and proportion.
11. QT Prolongation event assessed as Grade 3 or higher (Time Frame - up to week 116)
Secondary outcome:
1. Event-free survival (EFS) (Time Frame - up to week 116)
2. Proportion of patients who achieve a complete remission (CR) (Time Frame - up to week 116)
3. Proportion of patients who achieve complete remission plus complete remission with partial hematologic recovery rate (CR + CRh) (Time Frame - up to week 116)
4. Proportion of patients who achieve complete remission plus complete remission with incomplete hematologic recovery rate (CR + CRi) (Time Frame - up to week 116)
5. Duration of response (DOR) (Time Frame - up to week 116)
6. Time to response (TTR) (Time Frame - up to week 116)
7. Overall survival (OS) (Time Frame - until study closure)
8. Quality of life (QoL), as measured by Hematologic Malignancy-Patient-Reported Outcome (HM-PRO) (Time Frame - up to week 116): For patients with a baseline assessment and at least 1 post-baseline assessment that generates a score
9. Quality of life (QoL), as measured by Family Reported Outcome Measure (FROM-16), for caregivers and/or family (Time Frame - up to week 116): For patients with a baseline assessment and at least 1 post-baseline assessment that generates a score
10. Health economic measures, as assessed by the 5-level EuroQol 5-Dimensions (EQ-5D-5L) (Time Frame - up to week 116): For patients with a baseline assessment and at least 1 post-baseline assessment that generate a score
11. Average proportion of days at home (Time Frame - up to week 116): Defined by subtracting the number of care days (days hospitalized or seen in an ED / oncology clinic / infusion center) from the total days of follow-up, divided by total days of follow-up
Ivosidenib 500mg Oral Tablet: Provided as tablets, taken orally as two 250mg tablets once daily.
Azacitidine: Administered subcutaneously (SC) or intravenously (IV) at a dose of 75mg/m2/day for 7 days, either consecutively on Days 1-7 or discontinuously for Days 1-5 and 8-9 of each cycle. The 7 days of administration will occur at the beginning of every 4 week-long cycle.
Quelle: ClinicalTrials.gov
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"An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy."
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