Overview

This trial is active, not recruiting.

Condition langerhans cell histiocytosis of lung
Treatment cladribine
Phase phase 2
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2011
End date April 2017
Trial size 10 participants
Trial identifier NCT01473797, 2010-023344-32, AOM10182

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 histiocytosis and impairment of lung function patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cladribine
Subcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months

Primary Outcomes

Measure
Cumulated incidence of response to treatment
time frame: 6 months

Secondary Outcomes

Measure
Responses to treatment
time frame: 3 months
Absolute variations of FEV1, FVC, residual volume (RV), and Diffusing capacity of the lung for carbon monoxide (DLCO), (expressed in mL)
time frame: 6 months
Grade 3 or 4 neutropenia or thrombopenia
time frame: 6 months
Incidence of infection
time frame: 6 months
Incidence of grade 3 or 4 side effects
time frame: 6 months
Response to treatment of extra pulmonary localizations of the Langerhans disease
time frame: 6, 9, and 12 months
Incidence of pneumothorax
time frame: 12 months
Mortality
time frame: 12 months, 4 years
Incidence of secondary malignant disease
time frame: 4 years
Treatment response
time frame: at 6 months
Treatment response
time frame: 9 months
Treatment response
time frame: 12 months
Variation of nodular and cystic semiquantitative scores in High Resolution Computed Tomography (HRCT)
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Age 18 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

Additional Information

Official title Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
Principal investigator Abdellatif TAZI, MD, PhD
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 histiocytosis and impairment of lung function patients.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.