Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis (ECLA)
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ClinicalTrials.gov Identifier: NCT01473797 |
Recruitment Status : Unknown
Verified February 2021 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : February 18, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Langerhans Cell Histiocytosis of Lung | Drug: Cladribine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: cladribine |
Drug: Cladribine
Subcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months |
- 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
- 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 ]

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Ages Eligible for Study: | 16 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473797
France | |
Saint Louis hospital | |
Paris, France, 75010 |
Principal Investigator: | Abdellatif TAZI, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01473797 |
Other Study ID Numbers: |
AOM10182 2010-023344-32 ( EudraCT Number ) |
First Posted: | November 17, 2011 Key Record Dates |
Last Update Posted: | February 18, 2021 |
Last Verified: | February 2021 |
Histiocytosis, Langerhans-Cell Histiocytosis Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases |
Cladribine Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |