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Central China Rosai-Dorfman Disease Registry (CCR-DDR)

Primary Purpose

Rosai-Dorfman Disease, Langerhans Cell Histiocytosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mycophenolate mofetil combined with oral prednisone
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosai-Dorfman Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings. All participants will undergo Standard of Care MRA, CTA or imaging examination.

Exclusion Criteria:

Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma) Prior stroke or intracranial hemorrhage Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease) Existing diagnosis of a psychiatric disorder or untreated mood disturbance Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease Chronic or daily excessive alcohol consumption as determined by the PI. History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past History of severe claustrophobia or other contraindications to patient SOC brain MRI Prior intravenous cytarabine or cladribine Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance

Sites / Locations

  • Tongji HospitalRecruiting
  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mycophenolate mofetil

Arm Description

Mycophenolate mofetil oral 500mg twice a day from baseline to week 108

Outcomes

Primary Outcome Measures

Autoimmune bullous disease quality of life (ABQoL)
Total ABQoL scores range from 0 to 30 . The ABQoL score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Secondary Outcome Measures

Cumulative Oral Corticosteroid Dose
Calculate the Cumulative Oral Corticosteroid Dose

Full Information

First Posted
January 18, 2022
Last Updated
March 16, 2022
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05284942
Brief Title
Central China Rosai-Dorfman Disease Registry
Acronym
CCR-DDR
Official Title
A Trial to Evaluate the Long Term Prognosis in Rosai-Dorfman Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a research study among patients with Rosai-Dorfman disease.
Detailed Description
Rosai-Dorfman disease is a rare disorder characterized by overproduction (proliferation) and accumulation of a specific type of white blood cell (histiocyte) in the lymph nodes of the body (lymphadenopathy), most often those of the neck (cervical lymphadenopathy). In some cases, abnormal accumulation of histiocytes may occur in other areas of the body besides the lymph nodes (extranodal). These areas include the skin, central nervous system, kidney, and digestive tract. The symptoms and physical findings associated with Rosai-Dorfman disease vary depending upon the specific areas of the body that are affected. The disorder predominantly affects mainly adolescents or young adults. The exact cause of Rosa Dorfman disease is unknown. The purpose of this research study is to learn the prevalence , therapies and long term prognosis of Rosa Dorfman disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosai-Dorfman Disease, Langerhans Cell Histiocytosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Mycophenolate mofetil combined with stand of care of oral prednisone 5mg-15mg/day
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate mofetil
Arm Type
Experimental
Arm Description
Mycophenolate mofetil oral 500mg twice a day from baseline to week 108
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil combined with oral prednisone
Intervention Description
Mycophenolate mofetil oral 500mg twice a day combined with standard of care of oral prednisone 5mg-15mg/day from baseline to week 108
Primary Outcome Measure Information:
Title
Autoimmune bullous disease quality of life (ABQoL)
Description
Total ABQoL scores range from 0 to 30 . The ABQoL score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame
From baseline to 108 Weeks
Secondary Outcome Measure Information:
Title
Cumulative Oral Corticosteroid Dose
Description
Calculate the Cumulative Oral Corticosteroid Dose
Time Frame
From 12th, 24th, 36th ,52th and 108 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings. All participants will undergo Standard of Care MRA, CTA or imaging examination. Exclusion Criteria: Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma) Prior stroke or intracranial hemorrhage Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease) Existing diagnosis of a psychiatric disorder or untreated mood disturbance Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease Chronic or daily excessive alcohol consumption as determined by the PI. History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past History of severe claustrophobia or other contraindications to patient SOC brain MRI Prior intravenous cytarabine or cladribine Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YIKAI YU, M.D
Phone
+1-484-995-5917
Email
yuyikai0509@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
XIAO LUO, M.D
Email
lxf-692@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AIHUA DU, M.d
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YIKAI YU, M.D
Phone
+1-484-995-5917
Email
yuyikai0509@gmail.com
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AIHUA DU, M.D
Phone
+86 2783662886
First Name & Middle Initial & Last Name & Degree
YIKAI YU, M.D
First Name & Middle Initial & Last Name & Degree
SHAOXIAN HU, M.D
First Name & Middle Initial & Last Name & Degree
JIJUN YANG, M.D
First Name & Middle Initial & Last Name & Degree
WEI TU, M.D
First Name & Middle Initial & Last Name & Degree
RUI XING, M.D
First Name & Middle Initial & Last Name & Degree
MEI YU, M.D
First Name & Middle Initial & Last Name & Degree
CONG YE, M.D
First Name & Middle Initial & Last Name & Degree
FEI YU, M.D
First Name & Middle Initial & Last Name & Degree
GUIFEN SHEN, M.D
First Name & Middle Initial & Last Name & Degree
XIAOFANG LUO, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Central China Rosai-Dorfman Disease Registry

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