Status:
UNKNOWN
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Langerhans Cell Histiocytosis of Lung
Eligibility:
All Genders
16-55 years
Phase:
PHASE2
Brief Summary
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 h...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01473797
Start Date
November 1 2011
End Date
April 1 2022
Last Update
February 18 2021
Active Locations (1)
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1
Saint Louis hospital
Paris, France, 75010