Recruiting

A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol

What is being tested

Prednisone+Cytarabine+vincristine

+ Prednisone+Cytarabine+vincristine+Mercaptopurine

+ Prednisone+vincristine+Mercaptopurine

DrugOther

Who is being recruted

Hemic and Lymphatic Diseases+4

+ Histiocytosis, Langerhans-Cell

+ Lung Diseases

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorShanghai Children's Medical Center

Study ContactMeng Su, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2018

Actual date on which the first participant was enrolled.

All patients with de novo pathological confirmed LCH enrolled in this study will be classified into 4 groups. Group 1: Multisystem patients (≥2 organs/systems) with involvement of one or more "Risk" organs" (hematopoietic system, liver or spleen);Group 2:Multisystem patients, but without involvement of "Risk" organs; Group 3: Single system, Multifocal+ Single system, unifocal and special site@ (Isolated lesion of special site)+ Single system, unifocal and CNS risk+Single system, unifocal i.e. thyroid, lung, thymus, hypothalamic-pituitary+Single system, unifocal and other functionally critical anatomical sites; Group 4: Single system, unifocal i.e. bone, skin or lymph node (not the draining lymph node of another LCH lesion). For patients in Group 1, a 6-week initial treatment, a 16-week consolidation continuation treatment and a 26-week maintenance continuation treatment containing cytarabine is applied. For patients in Group 2, a 6-week initial treatment containing cytarabine and a 46-week continuation treatment (without cytarabine) is applied. For patients in Group 3,a 6-week initial treatment and a 46-week continuation treatment (without cytarabine) is applied. For patients in Group 4, only local therapy followed by wait-and-see strategy is applied.

Official TitleA Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol

NCT04773366

Principal SponsorShanghai Children's Medical Center

Study ContactMeng Su, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesHistiocytosis, Langerhans-CellLung DiseasesLymphatic DiseasesRespiratory Tract DiseasesHistiocytosisLung Diseases, Interstitial

Criteria

4 inclusion criteria required to participate

Age under 18 years

Newly diagnosed LCH：Morphologic identification of the characteristic LCH cells, positive staining of the lesional cells with CD1α and/or Langerin

No congenital immunodeficiency, HIV infection, or prior organ transplant

No previous chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage < prednisone 280 mg/m2

1 exclusion criteria prevent from participating

Patients have overwhelming infection, and a life expectancy of < 2 weeks

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Multisystem patients (≥2 organs/systems) with involvement of one or more "Risk" organs, i.e. hematopoietic system, liver or spleen. All patients in this group receive an initial therapy (Week 1\~6) followed by a consolidation continuation therapy (Week 7\~22) and maintenance continuation therapy (Week 25\~52).

Group II

Experimental

Multisystem patients, but without involvement of "Risk" organs. All patients in this group receive an initial therapy (Week 1\~6) followed by continuation therapy (Week 7\~52).

Group III

Experimental

Includes patients with single system, multifocal or with single system, unifocal and special site (Isolated lesion of special site) or with single system, unifocal and CNS risk or with single system, unifocal i.e. thyroid, lung, thymus, hypothalamic-pituitary or with single system, unifocal and other functionally critical anatomical sites. All patients in this group receive an initial therapy (Week 1\~6) followed by continuation therapy (Week 7\~52).

Group IV

Experimental

Patients with single system, unifocal i.e. bone, skin or lymph node (not the draining lymph node of another LCH lesion). All patients in this group enter into observation after local therapy. Chemotherapy only apply to patients with disease reactivation during observation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Children's Medical Center

Shanghai, ChinaOpen Shanghai Children's Medical Center in Google Maps

Recruiting

One Study Center