Langerhans Cell Histiocytosis of LungPhase 2ECLANCT01473797
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis
A Phase 2 study testing Cladribine in people with Langerhans Cell Histiocytosis of Lung, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Langerhans Cell Histiocytosis of Lung
- What is being tested?
- Cladribine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
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.
Read the 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.
- Conditions
- Langerhans Cell Histiocytosis of Lung
- Being tested
- Cladribine
- Medical subject headings
- Histiocytosis, Langerhans-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CladribineDrug
Subcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months
| Study group | Role | What they receive |
|---|---|---|
| cladribine | Experimental | Not described Receives: Drug: Cladribine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (13)
Responses to treatment
Measured: 3 months
Absolute variations of FEV1, FVC, residual volume (RV), and Diffusing capacity of the lung for carbon monoxide (DLCO), (expressed in mL)
Measured: 6 months
Grade 3 or 4 neutropenia or thrombopenia
Measured: 6 months
Incidence of infection
Measured: 6 months
Incidence of grade 3 or 4 side effects
Measured: 6 months
Response to treatment of extra pulmonary localizations of the Langerhans disease
Measured: 6, 9, and 12 months
Incidence of pneumothorax
Measured: 12 months
Mortality
Measured: 12 months, 4 years
Incidence of secondary malignant disease
Measured: 4 years
Treatment response
Measured: at 6 months
Treatment response
Measured: 9 months
Treatment response
Measured: 12 months
Variation of nodular and cystic semiquantitative scores in High Resolution Computed Tomography (HRCT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2018
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Langerhans Cell Histiocytosis of LungStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdellatif TAZI, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473797
- Sponsor's protocol ID
- AOM10182
- Other IDs
- 2010-023344-32
- Acronym
- ECLA
- Status last verified
- Feb 2021
- First submitted
- 14 Oct 2011
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 May 21;67(5):2501464. doi: 10.1183/13993003.01464-2025. Print 2026 May.
PubMed 41611252
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
- ClinicalTrials.gov ID
- NCT01473797
- Acronym / sponsor ID
- ECLA / AOM10182
- Conditions
- Langerhans Cell Histiocytosis of Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cladribine | Experimental | Drug: Cladribine |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
- Signed written informed consent
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CladribineSubcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months | Drug | cladribine |
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
13 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 41611252Benattia 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 May 21;67(5):2501464. doi: 10.1183/13993003.01464-2025. Print 2026 May.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdellatif TAZI, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cladribine in people with Langerhans Cell Histiocytosis of Lung, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated incidence of response to treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.