Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347996
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2011-05-02
Brief Title:
Maintenance Therapy With Ceplene Histamine and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
Sponsor:
Cytovia Inc
Organization:
Cytovia Inc
Study Overview
Official Title:
Open-Label Multicenter Effects of Remission Maintenance Therapy With Ceplene Given in Conjunction With Low-Dose Interleukin-2 on Immune Response and Minimal Residual Disease in Adult Patients With AML in First Complete Remission
Status:
COMPLETED
Status Verified Date:
2017-11
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:
None
Brief Summary:
CepleneIL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia AML in first complete remission This is an international multicenter open-label study to evaluate the effects of remission maintenance therapy with CepleneIL-2 in adult patients with AML in CR1 on specific immune system cells T and NK cells and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML
Detailed Description:
Outcome Measures
Primary
1 To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 CepleneIL-2 by monitoring T and natural killer NK cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia AML in first complete remission CR1
2 To evaluate minimal residual disease MRD in AML patients receiving CepleneIL-2
Secondary
To document in adult AML patients in CR1 treated with CepleneIL-2
1 Leukemia-free survival LFS after a follow-up period of up to two years
2 The safety of CepleneIL-2 therapy
3 The potential relationship of CepleneIL-2 effects on T and NK cell phenotypes and their functionality to MRD
Primary
1 To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 CepleneIL-2 by monitoring T and natural killer NK cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia AML in first complete remission CR1
2 To evaluate minimal residual disease MRD in AML patients receiving CepleneIL-2
Secondary
To document in adult AML patients in CR1 treated with CepleneIL-2
1 Leukemia-free survival LFS after a follow-up period of up to two years
2 The safety of CepleneIL-2 therapy
3 The potential relationship of CepleneIL-2 effects on T and NK cell phenotypes and their functionality to MRD
Study Oversight
Has Oversight DMC:
None
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?:
None