search
Back to results

Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis (MAALCH)

Primary Purpose

Langerhans Cell Histiocytosis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
methotrexate
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Langerhans Cell Histiocytosis focused on measuring adult with Langerhans cell histiocytosis, newly diagnosed, methotrexate, cytosine arabinoside

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Peking union medical college hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5

Outcomes

Primary Outcome Measures

disease free survival
time from treatment to disease progression

Secondary Outcome Measures

overall free survival
time from treatment to die

Full Information

First Posted
February 9, 2015
Last Updated
September 10, 2018
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02389400
Brief Title
Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis
Acronym
MAALCH
Official Title
Efficacy and Tolerance of Combination Chemotherapy With Methotrexate and Cytosine Arabinoside in Newly Diagnosed Adult With Langerhans Cell Histiocytosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Langerhans Cell Histiocytosis
Keywords
adult with Langerhans cell histiocytosis, newly diagnosed, methotrexate, cytosine arabinoside

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
methotrexate,1g/m2,iv.d1 cytosine arabinoside,0.1g/m2,iv.,d1-5
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
cytosine arabinoside
Intervention Description
Single Group Assignment
Primary Outcome Measure Information:
Title
disease free survival
Description
time from treatment to disease progression
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall free survival
Description
time from treatment to die
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Response
Description
The bone lesion response and the central nervous system（CNS）lesions response
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3.PRIOR CONCURRENT THERAPY: No prior treatment for Langerhans cell histiocytosis Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
minghui Duan, Dr.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32423455
Citation
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.
Results Reference
derived

Learn more about this trial

Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

We'll reach out to this number within 24 hrs