Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-01 @ 5:38 PM
Study NCT ID:
NCT03603795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2018-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy
Sponsor:
French Innovative Leukemia Organisation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPAG2015
Brief 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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: