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Search / Trial NCT04773366

A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · Feb 25, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Langerhans Cell Histiocytosis Pediatric Patients Cytarabine Treatment Outcome

ClinConnect Summary

This clinical trial is studying a new treatment for children diagnosed with Langerhans Cell Histiocytosis (LCH), a rare condition where the body produces too many LCH cells that can cause various health issues. The trial focuses on using a specific treatment plan that includes a medication called cytarabine. It aims to see how effective this new approach is in helping children, especially those with more serious symptoms, respond quickly to treatment and improve their chances of survival over time.

To be eligible for this trial, children must be under 18 years old and newly diagnosed with LCH, confirmed by specific tests. They should not have any serious infections or previous treatments like chemotherapy or radiation. Participants can expect to receive the new treatment protocol over an extended period and will be closely monitored for how well they respond. This study is important because it seeks to find better ways to treat LCH and improve outcomes for children facing this condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age under 18 years
  • 2. Newly diagnosed LCH:Morphologic identification of the characteristic LCH cells, positive staining of the lesional cells with CD1α and/or Langerin
  • 3. No congenital immunodeficiency, HIV infection, or prior organ transplant
  • 4. No previous chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage \< prednisone 280 mg/m2
  • Exclusion Criteria:
  • Patients have overwhelming infection, and a life expectancy of \< 2 weeks

About Shanghai Children's Medical Center

Shanghai Children's Medical Center is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and trials. As a prominent sponsor of clinical studies, the center focuses on a wide range of pediatric conditions, leveraging its state-of-the-art facilities and a team of expert clinicians and researchers. Committed to improving treatment outcomes and enhancing the quality of life for children, Shanghai Children's Medical Center collaborates with various healthcare organizations and academic institutions to drive forward-thinking research initiatives that address critical health challenges in the pediatric population.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Yi-Jin Gao, MD

Principal Investigator

Shanghai Children's Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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