NCT01473797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

6.4 years

First QC Date

October 14, 2011

Last Update Submit

February 17, 2021

Conditions

Langerhans Cell Histiocytosis of Lung

Outcome Measures

Primary Outcomes (1)

  • Cumulated incidence of response to treatment

    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

    6 months

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (1)

cladribine

EXPERIMENTAL
Drug: Cladribine

Interventions

CladribineDRUG

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

cladribine

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • Signed written informed consent

You may not qualify if:

  • 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
  • Previous treatment with cladribine
  • Contra indication to the use of cladribine
  • Previous myelosuppressive treatment
  • Simultaneous participation to another interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis hospital

Paris, 75010, France

Location

Related Publications (1)

  • Benattia A, Lorillon G, de Margerie-Mellon C, Vercellino L, Bonniaud P, Marquette CH, Chevret S, Tazi A. Efficacy and safety of cladribine in adult pulmonary langerhans cell histiocytosis: a phase II study. Eur Respir J. 2026 Jan 29:2501464. doi: 10.1183/13993003.01464-2025. Online ahead of print.

    PMID: 41611252DERIVED

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-ChloroadenosineAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxyadenosinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Abdellatif TAZI, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

November 17, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2018

Study Completion

April 1, 2022

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

FR(1)