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

• Status: Completed
• Trial end date: 2018-11-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

• Adults (18 years old)

• wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3)

• Absence of infection or other hematologic disease

• wAHAI not responding to conventional steroids despite a dose over 10 mg

• No treatment with rituximab for a minimum of 6 months

• Signed informed consent form

Exclusion Criteria:

• Less than 18 years old

• Cold AHAI

• IL2 allergy

• Chemiotherapy or immunosuppressive treatment

• Treatment with rituximab for less than 6 months

• Neoplasia or hematologic malignancy

• Aplastic anemia

• Neutropenia ≤ 1000 mm3

• Infection

• Hepatitis B or C

• wAHAI associated with systemic lupus erythematosus depending on ACR criteria

• Cardiac insufficiency

• Hypertension

• Pulmonary insufficiency

• Liver cirrhosis

• Thrombopenia below 50000/mm3

• Drug addiction, alcohol abuse

• Psychiatric disorder

• Absence of signed informed consent