NCT02389400CompletedPhase 2
Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis
Peking Union Medical College Hospital1 site in 1 country43 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- disease free survival
Study Overview
Brief Summary
Study Type: Interventional
Study Design:
Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside in newly diagnosed adult with Langerhans cell histiocytosis.
Detailed Description
This single arm clinical trial is studying efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside in newly diagnosed adult with Langerhans cell histiocytosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.DISEASE CHARACTERISTICS:
- •Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society
- •Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy
- •Considered at risk or low risk according to the following criteria:
- •Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)
- •1.No single-system lung involvement
- •Multi-system low-risk disease
- •1.Multiple organs involved but without involvement of risk organs
- •Single-system disease 1.Multifocal bone disease (i.e., lesions in 2 or more different bones) 2.Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension 3.Vault lesions are not regarded as CNS-risk lesions 2.PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception 3.PRIOR CONCURRENT THERAPY:
- •No prior treatment for Langerhans cell histiocytosis
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental arm
Experimental
methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5
Intervention: methotrexate (Drug)
Outcomes
Primary Outcomes
disease free survival
Time Frame: 5 years
time from treatment to disease progression
Secondary Outcomes
- overall free survival(5 years)
Investigators
Study Sites (1)
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