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Experimental immune therapy for stubborn anemia shows early promise but trial stalls

NCT ID NCT02389231

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested whether low doses of interleukin-2 (IL-2), a protein that helps regulate the immune system, could help people with warm autoimmune hemolytic anemia (wAHAI) whose disease did not improve with standard steroid treatment. The study planned to give four short courses of IL-2 injections over nine weeks and measure changes in certain immune cells and signs of red blood cell breakdown. However, the trial was terminated after enrolling only 2 participants, so no meaningful conclusions can be drawn about safety or effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Interleukin-2 (IL-2, also called Proleukin or aldesleukin)
What this could lead to
If it works, this could point toward a new treatment option for people with warm hemolytic anemia who don't respond to standard steroids.
What could go wrong
This was a very early, small trial (only 2 participants) that was terminated, so we don't know if it's safe or effective. The results are too limited to draw any conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

2 people

The number who actually took part.

Started

May 2017

Finished

Nov 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia autoimmune hemolytic anemia, warm type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hemolytic anemia

Contacts and locations

Locations

  • CHU de Bordeaux Hôpital Haut Lévêque

    Pessac, Aquitaine, 33604, France

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