Treatment for children with newly diagnosed Langerhans Cell Histiocytosis using cytarabine
A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol
This study is testing a new treatment plan using cytarabine for children with newly diagnosed Langerhans Cell Histiocytosis to see if it helps them respond better and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Shanghai Children's Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04773366 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a modified treatment protocol using cytarabine for children diagnosed with Langerhans Cell Histiocytosis (LCH). Participants will be classified into four groups based on the severity and extent of their disease, with tailored treatment regimens including initial, consolidation, and maintenance phases. The study will monitor treatment outcomes, including response rates and overall survival over a three-year period. The goal is to improve treatment strategies for pediatric patients with LCH, particularly those with multisystem involvement.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have been newly diagnosed with LCH and meet specific inclusion criteria.
Not a fit: Patients with overwhelming infections or a life expectancy of less than two weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for children with LCH.
How similar studies have performed: Previous studies have shown varying success with treatment protocols for LCH, but this specific approach using cytarabine is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Shanghai Children's Medical Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yi-Jin Gao, MD — Shanghai Children's Medical Center
- Study coordinator: Meng Su, MD
- Email: sumeng@scmc.com.cn
- Phone: 0086-18817821853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.