NCT03603795

Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study

Detailed description

Subjects will be randomized 1:1 to receive Eltrombopag or matching placebo, in double blinded. To compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy Arm A : Eltrombopag 200 mg (100 mg/day for east Asian heritage) once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \> 100 x 10 Giga/L (maximum day 45) Arm B : Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \> 100 x 10 Giga/L. (maximum day 45)

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Eltrombopag	Eltrombopag concomitant with induction chemotherapy in patient with AML
DRUG	Placebo	Placebo concomitant with induction chemotherapy patients with AML

Timeline

• Start date: 2018-10-11
• Primary completion: 2022-06-15
• Completion: 2026-07-30
• First posted: 2018-07-27
• Last updated: 2024-10-29

Locations

15 sites across 1 country: France