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
|
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 |
disease free survival [ Time Frame: 5 years ] time from treatment to disease progression
|
|||
Original Primary Outcome Measures ICMJE |
disease free survival [ Time Frame: 5 years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
overall free survival [ Time Frame: 5 years ] time from treatment to die
|
|||
Original Secondary Outcome Measures ICMJE |
overall free survival [ Time Frame: 5 years ] | |||
Current Other Pre-specified Outcome Measures |
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 |
43 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria: |
|||
Sex/Gender ICMJE |
|
|||
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 |
|
|||
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 |