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LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

NCT02205762 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2026-04-09

No results posted yet for this study

Summary

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age \< 18 years).

Conditions

  • Langerhans Cell Histiocytosis

Interventions

DRUG

Prednisone

Stratum I

DRUG

Vinblastine

Stratum I

DRUG

mercaptopurine

Stratum I

DRUG

INDOMETHACIN

Indomethacin fixed dose given daily orally in two divided doses with gastric protection for total treatment duration of 24 months.

DRUG

Methotrexate

fixed dose weekly orally for total treatment duration of 24 months.

DRUG

Cytosine Arabinoside

DRUG

2-chlorodeoxyadenosine

PROCEDURE

hematopoietic stem cell transplantation (RIC-HSCT)

BIOLOGICAL

Intravenous immunoglobulin

Sponsors & Collaborators

  • Histiocyte Society

    collaborator OTHER

  • North American Consortium for Histiocytosis

    lead OTHER

Principal Investigators

  • Milen Minkov, MD, Ph.D · Children's Cancer Research Institute / St. Anna Children's Hospital

  • Carlos Rodriguez-Galindo, MD · North American Consortium for Histiocytosis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-02
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205762 on ClinicalTrials.gov