NCT02389231

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

February 13, 2015

Last Update Submit

May 20, 2026

Conditions

Autoimmune Hemolytic Anemia

Keywords

interleukine 2warm autoimmune hemolytic anemiaCD8 regulatory T cells

Outcome Measures

Primary Outcomes (1)

  • Percentage of LTCD8+CD25highFoxp3+ .

    Increase of the percentage of LTCD8+CD25highFoxp3+ at the end of the IL2 treatment.

    9 weeks after inclusion

Secondary Outcomes (5)

  • Incidence of complications with the treatment.

    6 months after inclusion

  • Hemolysis as measured by hemoglobin, haptoglobin, reticulocytes and LDH levels

    5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion

  • Evaluation of lymphocyte sub-populations

    5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion

  • Evaluation of lymphocyte activation.

    5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion

  • Dose of steroid treatment

    5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion

Study Arms (1)

Low doses of Interleukine-2

EXPERIMENTAL

Low doses of Interleukine-2 over a 9 week treatment period

Drug: Interleukine-2

Interventions

Interleukine-2DRUG

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.

Also known as: PROLEUKIN 18M, aldesleukine
Low doses of Interleukine-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux Hôpital Haut Lévêque

Pessac, Aquitaine, 33604, France

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Estibaliz LAZARO, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Rodolphe THIEBAUT, Prof

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 17, 2015

Study Start

May 17, 2017

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

FR(1)