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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

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date September 12, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
disease free survival [ Time Frame: 5 years ]
time from treatment to disease progression
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
disease free survival [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
overall free survival [ Time Frame: 5 years ]
time from treatment to die
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
overall free survival [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures
 (submitted: September 10, 2018)
Response [ Time Frame: 2 years ]
The bone lesion response and the central nervous system(CNS)lesions response
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis
Official Title  ICMJE Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Langerhans Cell Histiocytosis
Intervention  ICMJE Drug: methotrexate
Single Group Assignment
Other Name: cytosine arabinoside
Study Arms  ICMJE Experimental: Experimental arm
methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5
Intervention: Drug: methotrexate
Publications * Han X, Ouyang M, Duan M, Zhang W, Zhu T, Li J, Wang S, Zhou D. The combination of methotrexate and cytosine arabinoside in newly diagnosed adult Langerhans cell histiocytosis: a prospective phase II interventional clinical trial. BMC Cancer. 2020 May 18;20(1):433. doi: 10.1186/s12885-020-06872-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2015)
30
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02389400
Other Study ID Numbers  ICMJE ALCH-MA-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: minghui Duan, Dr. Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP