Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02389231
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2015-02-13
Brief Title:
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Anemil Trial Phase III Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
Status:
COMPLETED
Status Verified Date:
2019-02
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:
ANEMIL
Brief Summary:
The investigators have demonstrated that the mean percentage of circulating CD8 regulatory T CD8 Tregs cells is significantly higher in patients with warm hemolytic anemia wAHAI in remission than in controls and is correlated to hemoglobin levels In vitro low dose of interleukine-2 IL2 induce the expansion of CD8 Tregs The objective is to demonstrate that over a 9 week treatment period low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI
Detailed Description:
wAIHA is a B-cell-mediated autoimmune disease in which red blood cells are targeted by autoantibodies which leads to marked decrease in their lifespan The investigators demonstrated two years ago in a multivariate retrospective study that the CD3CD8 HLA-DR T-cell population was associated to a better outcome The investigators observed that the proportion of circulating CD3CD8CD25highFoxp3 T cells was significantly higher in patients with wAIHA in remission than in controls and correlated to hemoglobin levels Extensive phenotyping and functional analysis revealed that those cells were bona fide Tregs acting in an IL10-dependent manner Finally culture of PBMC from normal donors or active wAIHAI patients with low dose of IL2 promoted the expansion of functional CD3CD8CD25Foxp3 Those observations constituted the rationale to propose low dose of IL2 to treat patients with active wAIHA with the objective of demonstrating that this treatment is able to induce the expansion of CD8Tregs over a 9 week treatment period
Four courses of IL2 aldesleukin Proleukin Novartis will be administered subcutaneously for 5 days The first course will be limited to a dose of 15 million IU per day and followed by a 9 day wash-out The other courses of 3 million IU per day will be initiated after a 16 day wash-out
Patients will be evaluated on day 1 and day 5 of each treatment course before the first and last administration of interleukin-2 and will also be evaluated at 6 months
Four courses of IL2 aldesleukin Proleukin Novartis will be administered subcutaneously for 5 days The first course will be limited to a dose of 15 million IU per day and followed by a 9 day wash-out The other courses of 3 million IU per day will be initiated after a 16 day wash-out
Patients will be evaluated on day 1 and day 5 of each treatment course before the first and last administration of interleukin-2 and will also be evaluated at 6 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None