Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

Langerhans Cell Histiocytosis Clinical Trial

— MAALCH  

Official title:

Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389400
• Other study ID #: ALCH-MA-001
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

Related Conditions & MeSH terms

• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Langerhans Cell Histiocytosis

Intervention

Drug:
• methotrexate
Single Group Assignment

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response	The bone lesion response and the central nervous system(CNS)lesions response	2 years
Primary	disease free survival	time from treatment to disease progression	5 years
Secondary	overall free survival	time from treatment to die	5 years