Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-28 @ 10:31 AM
Study NCT ID:
NCT01369368
Status:
UNKNOWN
Last Update Posted:
2015-06-24
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Acute Leukemia Relapse After Allotransplantation
Sponsor:
University of Bergen
Organization:
Study Overview
Official Title:
Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
Status:
UNKNOWN
Status Verified Date:
2015-06
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:
None
Brief Summary:
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
Detailed Description:
None
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?: