Autoimmune Hemolytic AnemiaPhase 1/2ANEMILNCT02389231
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
A Phase 1/2 study testing Interleukine-2 in people with Autoimmune Hemolytic Anemia, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- Interleukine-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2017to 16 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 CD3+CD8+ HLA-DR+ T-cell population was associated to a better outcome. The investigators observed that the proportion of circulating CD3+CD8+CD25highFoxp3+ 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 CD3+CD8+CD25+Foxp3+. 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 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.
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.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- Interleukine-2
- Keywords
- interleukine 2, warm autoimmune hemolytic anemia, CD8 regulatory T cells
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukine-2Drug
Also called PROLEUKIN 18M, aldesleukine
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.
| Study group | Role | What they receive |
|---|---|---|
| Low doses of Interleukine-2 | Experimental | Low doses of Interleukine-2 over a 9 week treatment period Receives: Drug: Interleukine-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of LTCD8+CD25highFoxp3+ .
Increase of the percentage of LTCD8+CD25highFoxp3+ at the end of the IL2 treatment.
Measured: 9 weeks after inclusion
Secondary outcomes (5)
Incidence of complications with the treatment.
Safety of the treatment during the trial and 6 months after the inclusion
Measured: 6 months after inclusion
Hemolysis as measured by hemoglobin, haptoglobin, reticulocytes and LDH levels
Impact of IL2 on hemolysis defined by hemoglobin, haptoglobin, reticulocytes, LDH levels
Measured: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Evaluation of lymphocyte sub-populations
Impact of IL2 on lymphocyte sub-populations (NK cells, B lymphocyte, CD4T lymphocyte, CD8T lymphocytes, CD4Tregs levels) at each time point of evaluation.
Measured: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Evaluation of lymphocyte activation.
Impact of IL2 on lymphocyte activation defined by DR expression at each time point of evaluation.
Measured: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Dose of steroid treatment
Impact of IL2 on steroid treatment (dose) during the trial and 6 months after the inclusion
Measured: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start17 May 2017
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Why it stopped: target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estibaliz LAZARO, Prof, Principal investigator, University Hospital, BordeauxRodolphe THIEBAUT, Prof, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389231
- Sponsor's protocol ID
- CHUBX 2013/29
- Other IDs
- 2014-002315-42, 2014
- Acronym
- ANEMIL
- Status last verified
- May 2026
- First submitted
- 13 Feb 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02389231
- Acronym / sponsor ID
- ANEMIL / CHUBX 2013/29
- Conditions
- Autoimmune Hemolytic Anemia
- Keywords
- interleukine 2, warm autoimmune hemolytic anemia, CD8 regulatory T cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 CD3+CD8+ HLA-DR+ T-cell population was associated to a better outcome. The investigators observed that the proportion of circulating CD3+CD8+CD25highFoxp3+ 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 CD3+CD8+CD25+Foxp3+. 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low doses of Interleukine-2 | Experimental | Drug: Interleukine-2Low doses of Interleukine-2 over a 9 week treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- Less than 18 years old
- Cold AHAI
- IL2 allergy
- Chemiotherapy or immunosuppressive treatment
- Treatment with rituximab for less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukine-2Also: PROLEUKIN 18M, aldesleukineFour 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. | Drug | Low doses of Interleukine-2 |
Primary outcome
Percentage of LTCD8+CD25highFoxp3+ .
Time frame: 9 weeks after inclusion
Increase of the percentage of LTCD8+CD25highFoxp3+ at the end of the IL2 treatment.
5 secondary outcomes
Incidence of complications with the treatment.
Time frame: 6 months after inclusion
Hemolysis as measured by hemoglobin, haptoglobin, reticulocytes and LDH levels
Time frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Evaluation of lymphocyte sub-populations
Time frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Evaluation of lymphocyte activation.
Time frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Dose of steroid treatment
Time frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estibaliz LAZARO, Prof principal investigator
University Hospital, Bordeaux
Rodolphe THIEBAUT, Prof study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interleukine-2 in people with Autoimmune Hemolytic Anemia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of LTCD8+CD25highFoxp3+ . (time frame: 9 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.