Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT02502968
Status:
UNKNOWN
Last Update Posted:
2015-09-21
First Post:
2015-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BL-8040 Addition to Consolidation Therapy in AML Patients
Sponsor:
Dr. Petra Tschanter
Organization:
Study Overview
Official Title:
A Double- Blind, Placebo Controlled, Randomized, Multicenter, Phase II Study to Assess the Efficacy of BL-8040 Addition to Consolidation Therapy in AML Patients
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
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:
BLAST
Brief Summary:
This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.
Detailed Description:
The majority of AML patients in first complete Remission (CR) do relapse despite the current consolidation therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Allogenic stem cell transplantation is an option only for a minority of AML patients in 1st CR. BL-8040 is a novel CXCR4 inhibitor that has a dual mechanism of action: inducing mobilization of leukemic blasts from the bone marrow which enhances cytotoxic effects of chemotherapy and has direct antileukemic, pro-apoptotic properties. The treatment with BL-8040 in combination with consolidation therapy (standard consolidation with high-dose cytarabine) should improve the efficacy of the consolidation therapy resulting in longer lasting remissions.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: