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Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis
NCT02389400Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Sep 2017
- Countries
- 1
- Sponsor
- Peking Union Medical College Hospital
- Modality
- Orthosteric Ligands
- Conditions
- Langerhans cell histiocytosis (LCH)
01
Overview
Phase 2, open-label, single-arm trial of methotrexate and cytarabine in Langerhans cell histiocytosis (LCH), sponsored by Peking Union Medical College Hospital. Primary endpoint: Disease-Free Survival at 5 years. Started Jan 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Experimental arm
methotrexate + cytosine arabinoside
03
Who it enrols
Adults with newly diagnosed, histopathologically confirmed Langerhans cell histiocytosis (CD1a+ or Birbeck granules) with no prior treatment.
04
Endpoints
Primary
Disease-Free Survival
Secondary
Overall Survival
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