Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis

Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
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 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.

Overall Status Active, not recruiting
Start Date 2011-11-01
Completion Date 2022-04-01
Primary Completion Date 2018-04-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Cumulated incidence of response to treatment 6 months
Secondary Outcome
Measure Time Frame
Responses to treatment 3 months
Absolute variations of FEV1, FVC, residual volume (RV), and Diffusing capacity of the lung for carbon monoxide (DLCO), (expressed in mL) 6 months
Grade 3 or 4 neutropenia or thrombopenia 6 months
Incidence of infection 6 months
Incidence of grade 3 or 4 side effects 6 months
Response to treatment of extra pulmonary localizations of the Langerhans disease 6, 9, and 12 months
Incidence of pneumothorax 12 months
Mortality 12 months, 4 years
Incidence of secondary malignant disease 4 years
Treatment response at 6 months
Treatment response 9 months
Treatment response 12 months
Variation of nodular and cystic semiquantitative scores in High Resolution Computed Tomography (HRCT) 6 months
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cladribine

Description: Subcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months

Arm Group Label: cladribine

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

16 Years

Maximum Age:

55 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Abdellatif TAZI, MD, PhD Principal Investigator Assistance Publique - Hôpitaux de Paris
Location
Facility: Saint Louis hospital
Location Countries

France

Verification Date

2021-02-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: cladribine

Type: Experimental

Acronym ECLA
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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