Clinical Trial: Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
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 histiocytosis and impairment of lung function patients.
Detailed 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Cumulated incidence of response to treatment [ Time Frame: 6 months ]
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
Original Primary Outcome: Cumulated incidence of response to treatment [ Time Frame: 6 months ]
response to treatment after 6 months is defined as
- ≥10% improvement of FVC
- and/or ≥10% improvement of postbronchodilator FEV1 and ≥200ml
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Responses to treatment [ Time Frame: 3 months ]
- Absolute variations of FEV1, FVC, RV, and DLCO(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 LCH localizations [ 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 HRCT [ Time Frame: 6 months ]
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: October 14, 2011
Date Started: November 2011
Date Completion: April 2018
Last Updated: September 28, 2016
Last Verified: September 2016