Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis (MAALCH)

• ClinicalTrials.gov Identifier: NCT02389400
• Recruitment Status: Completed
• First Posted: March 17, 2015
• Last Update Posted: September 12, 2018
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Peking Union Medical College Hospital

Tracking Information

• First Submitted Date: February 9, 2015
• First Posted Date: March 17, 2015
• Last Update Posted Date: September 12, 2018
• Study Start Date: January 2014
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2018)

disease free survival [ Time Frame: 5 years ]

time from treatment to disease progression

• Original Primary Outcome Measures (submitted: March 10, 2015): disease free survival [ Time Frame: 5 years ]

Current Secondary Outcome Measures (submitted: September 10, 2018)

overall free survival [ Time Frame: 5 years ]

time from treatment to die

• Original Secondary Outcome Measures (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: Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Langerhans Cell Histiocytosis

Intervention

Drug: methotrexate

Single Group Assignment

Other Name: cytosine arabinoside

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2018): 43
• Original Estimated Enrollment (submitted: March 10, 2015): 30
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility 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:

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02389400
• Other Study ID Numbers: ALCH-MA-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Peking Union Medical College Hospital
• Study Sponsor: Peking Union Medical College Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: minghui Duan, Dr.; Peking Union Medical College Hospital

• PRS Account: Peking Union Medical College Hospital
• Verification Date: August 2017