NCT02389400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 12, 2018

Status Verified

August 1, 2017

Enrollment Period

3.7 years

First QC Date

February 9, 2015

Last Update Submit

September 10, 2018

Conditions

Langerhans Cell Histiocytosis

Keywords

adult with Langerhans cell histiocytosisnewly diagnosedmethotrexatecytosine arabinoside

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    time from treatment to disease progression

    5 years

Secondary Outcomes (1)

  • overall free survival

    5 years

Other Outcomes (1)

  • Response

    2 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

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

Drug: methotrexate

Interventions

methotrexateDRUG

Single Group Assignment

Also known as: cytosine arabinoside
Experimental arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • No single-system lung involvement
  • Multi-system low-risk disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, 100730, China

Location

Related Publications (1)

  • 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.

    PMID: 32423455DERIVED

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Interventions

MethotrexateCytarabine

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • minghui Duan, Dr.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 17, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 12, 2018

Record last verified: 2017-08

Locations

CN(1)