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

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ClinicalTrials.gov Identifier: NCT01473797
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Langerhans Cell Histiocytosis of Lung Drug: Cladribine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Responses to treatment [ Time Frame: 3 months ]
  2. 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 ]
  3. Grade 3 or 4 neutropenia or thrombopenia [ Time Frame: 6 months ]
  4. Incidence of infection [ Time Frame: 6 months ]
  5. Incidence of grade 3 or 4 side effects [ Time Frame: 6 months ]
  6. Response to treatment of extra pulmonary localizations of the Langerhans disease [ Time Frame: 6, 9, and 12 months ]
  7. Incidence of pneumothorax [ Time Frame: 12 months ]
  8. Mortality [ Time Frame: 12 months, 4 years ]
  9. Incidence of secondary malignant disease [ Time Frame: 4 years ]
  10. Treatment response [ Time Frame: at 6 months ]
  11. Treatment response [ Time Frame: 9 months ]
  12. Treatment response [ Time Frame: 12 months ]
  13. 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:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Saint Louis hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Abdellatif TAZI, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01473797     History of Changes
Other Study ID Numbers: AOM10182
2010-023344-32 ( EudraCT Number )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs