Langerhans Cell Histiocytosis of Lung Clinical Trial
— ECLAOfficial title:
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
| Verified date | February 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | April 2022 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 55 Years |
| Eligibility | 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Saint Louis hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulated incidence of response to treatment | response to treatment after 6 months is defined as
=10% improvement of forced vital capacity (FVC) and/or =10% improvement of postbronchodilator forced expiratory volume (FEV1) and =200ml |
6 months | |
| Secondary | Responses to treatment | 3 months | ||
| Secondary | Absolute variations of FEV1, FVC, residual volume (RV), and Diffusing capacity of the lung for carbon monoxide (DLCO), (expressed in mL) | 6 months | ||
| Secondary | Grade 3 or 4 neutropenia or thrombopenia | 6 months | ||
| Secondary | Incidence of infection | 6 months | ||
| Secondary | Incidence of grade 3 or 4 side effects | 6 months | ||
| Secondary | Response to treatment of extra pulmonary localizations of the Langerhans disease | 6, 9, and 12 months | ||
| Secondary | Incidence of pneumothorax | 12 months | ||
| Secondary | Mortality | 12 months, 4 years | ||
| Secondary | Incidence of secondary malignant disease | 4 years | ||
| Secondary | Treatment response | at 6 months | ||
| Secondary | Treatment response | 9 months | ||
| Secondary | Treatment response | 12 months | ||
| Secondary | Variation of nodular and cystic semiquantitative scores in High Resolution Computed Tomography (HRCT) | 6 months |