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Trial record 1 of 1 for:    NCT02389400
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Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis (MAALCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389400
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Langerhans Cell Histiocytosis Drug: methotrexate Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis
Study Start Date : January 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm
methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5
 Drug: methotrexate
Single Group Assignment
Other Name: cytosine arabinoside


Outcome Measures
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Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
    time from treatment to disease progression


Secondary Outcome Measures :
  1. overall free survival [ Time Frame: 5 years ]
    time from treatment to die


Other Outcome Measures:
  1. Response [ Time Frame: 2 years ]
    The bone lesion response and the central nervous system（CNS）lesions response


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389400


Locations
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China
Peking union medical college hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: minghui Duan, Dr. Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02389400    
Other Study ID Numbers: ALCH-MA-001
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: August 2017
Keywords provided by Peking Union Medical College Hospital:
adult with Langerhans cell histiocytosis
newly diagnosed
methotrexate
cytosine arabinoside
Additional relevant MeSH terms:
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Histiocytosis, Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors