autoimmune enteropathy (AIE) in common variable immunodeficiency (CVID). MedDRA version: 19.0 Level: PT Classification code 10021449 Term: Immunodeficiency common variable System Organ Class: 10021428 - Immune system disorders MedDRA version: 19.0 Level: LLT Classification code 10017922 Term: Gastroenteropathy NOS System Organ Class: 100000004856
Conditions
Interventions
Trade Name: PROLEUKIN® S
Product Name: Aldesleukin
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Aldesleukin
CAS Number: 110942-02-4
Other descriptive name: ALDE
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patient with a diagnosis of CVID according to the ESID criteria (www.esid.org) Sufficient IgG replacement therapy for at least 6 months with IgG trough levels above 6g/l. Diagnosis of autoimmune enteropathy of the upper gastrointestinal tract proven by histology. Last biopsy =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Need for a scheduled application of contrast agent during the trial. Patients with malignant neoplasm within the last 5 years prior to visit 1 (except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix). Patients with an ECOG = 2. Patients with a history of or current severe cardiac or pulmonary disease or uncontrolled pericardial or pleural effusion. Patients with thrombosis or thromboembolic event 1.25 ULN), hepatic (AST > 3 ULN, bilirubin > 1.5 x ULN) or other severe organ impairment. Preexisting cytopenia (hematocrit <30%, thrombocytes <100.000/µl, leukocytes <3.000/µl or neutrophils <1.500/µl or CD4 cell counts <100/ µl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To assess the safety (esp. with respect to autoimmunity) of different doses of low-dose s.c. Aldesleukin treatment in CVID patients with AIE ;Secondary Objective: Secondary objectives: To assess the optimal dose for expansion of Treg cells in CVID patients. To assess the impact of low-dose Aldesleukin on chronic diarrhoea in patients with AIE and CVID.;Primary end point(s): Primary safety endpoint: Adverse events will be recorded according to GCP guidelines during the treatment and follow-up phase at every site visit (every two weeks). Patients will be clinically monitored for signs of autoimmunity at every site visit. Autoantibodies will be measured before start of the therapy and after completion of the follow-up period. Differential blood count (eosinophil counts), lymphocyte subsets as well as liver enzymes and creatinine will be measured every two weeks. ;Timepoint(s) of evaluation of this end point: Data from at least 33 treatment cycles (n=3 patients fulifilling the whole treatment period) will be analysed. Regression models will be used to describe the relation of the different outcomes to dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint(s): % of Tregs will be measured before each cycle and on day 4 of every cycle and on day 6 of the induction cycle(s). Disease activity will be assessed with a self-administered questionnaire (IBDQ) and a stool diary filled in by patients.;Timepoint(s) of evaluation of this end point: Data from at least 33 treatment cycles (n=3 patients fulifilling the whole treatment period) will be analysed. Regression models will be used to describe the relation of the different outcomes to dose. | — |
Countries
Germany
Contacts
Public ContactLeiter der Klinischen Prüfung
Universitätsklinikum Freiburg
Outcome results
None listed