Status:
RECRUITING
A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol
Lead Sponsor:
Shanghai Children's Medical Center
Conditions:
Langerhans Cell Histiocytosis
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
From January 2010 to December 2014, 150 children with MS-LCH were treated in our hospital following a LCH II (Arm B) based protocol. Treatment was based on a modification of the LCH-II (Arm B) based p...
Detailed Description
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" o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients have overwhelming infection, and a life expectancy of \< 2 weeks
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04773366
Start Date
July 1 2018
End Date
June 30 2026
Last Update
July 26 2022
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, China