Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cytarabine; Methotrexate

Criteria

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:

1. Not pregnant or nursing

2. Negative pregnancy test

3. Fertile patients must use effective contraception 3.PRIOR CONCURRENT THERAPY:

1. No prior treatment for Langerhans cell histiocytosis

Exclusion Criteria: