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TERMINATED
NCT02389231
PHASE1/PHASE2

Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Official title: " Anemil Trial ": Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2017-05-17

Completion Date

2018-11-16

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Interleukine-2

Four courses of IL2 ( \[Proleukin, Novartis\]) will be administered subcutaneously for 5 days. The first course will be limited to a dose of 1.5 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.

Locations (1)

CHU de Bordeaux Hôpital Haut Lévêque

Pessac, Aquitaine, France