Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

Phase 2

Completed

• Conditions: Langerhans Cell Histiocytosis
• Interventions: Drug: methotrexate

• Registration Number: NCT02389400
• Lead Sponsor: Peking Union Medical College Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Status Verified: 2017-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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:
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    1. No prior treatment for Langerhans cell histiocytosis

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	methotrexate	methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years	time from treatment to disease progression

Secondary Outcome Measures

Name	Time	Method
overall free survival	5 years	time from treatment to die

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, China