TerminatedPhase 1/2

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

Stopped: target number of inclusion not reached

France2 participantsStarted 2017-05-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of LTCD8+CD25highFoxp3+ .

Timeframe: 9 weeks after inclusion

Trial details

NCT IDNCT02389231

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-16

View on ClinicalTrials.gov More Autoimmune Hemolytic Anemia trials