Central China Rosai-Dorfman Disease Registry

NCT05284942 | Unknown Phase 4 DMC

• 1 other identifier: Tongji0509
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This is a research study among patients with Rosai-Dorfman disease.

Conditions

Rosai-Dorfman Disease; Langerhans Cell Histiocytosis

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 108 Weeks

Secondary Outcomes (1)

• Cumulative Oral Corticosteroid Dose

  From 12th, 24th, 36th ,52th and 108 Weeks

Study Arms (1)

Mycophenolate mofetil

EXPERIMENTAL

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

Drug: Mycophenolate mofetil combined with oral prednisone

Interventions

Mycophenolate mofetil combined with oral prednisone DRUG

Mycophenolate mofetil oral 500mg twice a day combined with standard of care of oral prednisone 5mg-15mg/day from baseline to week 108

Mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Histiocytosis, Sinus; Histiocytosis, Langerhans-Cell

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• AIHUA DU, M.d

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

YIKAI YU, M.D

CONTACT

+1-484-995-5917; yuyikai0509@gmail.com

XIAO LUO, M.D

CONTACT

lxf-692@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mycophenolate mofetil combined with stand of care of oral prednisone 5mg-15mg/day

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: March 17, 2022
• Study Start: October 1, 2011
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)