Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02545283
Status:
TERMINATED
Last Update Posted:
2022-01-11
First Post:
2015-08-31
Brief Title:
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia AML
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Placebo-Controlled Phase III Study of Idasanutlin an MDM2 Antagonist With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia AML
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped for futility based on efficacy results at the interim analysis no unexpected safety findings were observed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRROS
Brief Summary:
This is a multicenter double-blind randomized placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine Participants will receive induction treatment with idasanutlinplacebo and cytarabine Cycle 1 Responding participants may continue to receive a maximum of further two cycles of consolidation Cycle 2 and Cycle 3 Complete remission CR CR with incomplete platelet count recovery CRp overall remission rate ORR event-free survival EFS and percentage of participants with an allogeneic hematopoietic stem cell transplant HSCT will also be compared between treatment arms This study will include participants with and without TP53 wild type TP53 WT mutations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-003065-15 | EUDRACT_NUMBER | None | None |