Informations générales (source: ClinicalTrials.gov)
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function (ECLA)
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2011
avril 2022
29 juin 2024
ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during
5 days, administrated every month for 4 courses, in symptomatic adult patients with
pulmonary Langerhans cell histiocytosis and impairment of lung function patients.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Saint Louis hospital - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age 16 to 55 yr
- Histologically proven pulmonary Langerhans cell histiocytosis ( patients with
presumptive diagnosis whose lung function precludes lung biopsy may be included
after revision of their medical record at the national reference center for
Langerhans cell histiocytosis)
- Symptomatic pulmonary Langerhans cell histiocytosis (NYHA dyspnea class ≥2) with:
- irreversible airflow obstruction (FEV1/FVC<70%) with postbronchodilator FEV1
comprised between 30 and 70% of predicted
- and/or decrease ≥15% in FEV1, FVC or DLCO as compared to baselines values in
the year preceding the inclusion
- Signed written informed consent
- Age 16 to 55 yr
- Histologically proven pulmonary Langerhans cell histiocytosis ( patients with
presumptive diagnosis whose lung function precludes lung biopsy may be included
after revision of their medical record at the national reference center for
Langerhans cell histiocytosis)
- Symptomatic pulmonary Langerhans cell histiocytosis (NYHA dyspnea class ≥2) with:
- irreversible airflow obstruction (FEV1/FVC<70%) with postbronchodilator FEV1
comprised between 30 and 70% of predicted
- and/or decrease ≥15% in FEV1, FVC or DLCO as compared to baselines values in
the year preceding the inclusion
- Signed written informed consent
- Women at childbearing age without adequate contraception or wishing breastfeeding
- Male without adequate contraception during the study
- Dyspnea due to severe pulmonary arterial hypertension (PAP≥35mmHg) confirmed by
cardiac right catheterism
- Previous malignancy
- Current infectious disease
- Renal failure
- Liver failure
- Severe alteration of lung
- Hematologic disease unrelated to Langerhans cell histiocytosis
- Epilepsy
- Hepatic, spleen or hematology involvement by Langerhans cell histiocytosis
- Pneumothorax within a month previously to inclusion
- Previous treatment with cladribine
- Contra indication to the use of cladribine
- Previous myelosuppressive treatment
- Simultaneous participation to another interventional clinical trial