Rituximab for HTLV-1-associated Myelopathy
Primary Purpose
HTLV-1-associated Myelopathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for HTLV-1-associated Myelopathy
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 years
- Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
Exclusion Criteria:
- Anticipated survival of at least 3 years
- Inability to undergo neuroimaging with Magnetic Resonance
- Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
- Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
- Pregnancy
- Malignancy (history of or active)
- Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies
Sites / Locations
- Department of Neurology ,First Affiliated Hospital Fujian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rituximab group
Control group
Arm Description
Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused
Patients will receive usual care and drug use.
Outcomes
Primary Outcome Measures
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions
Secondary Outcome Measures
Change in immunology function
Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use
Full Information
NCT ID
NCT04004819
First Posted
June 27, 2019
Last Updated
April 12, 2022
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04004819
Brief Title
Rituximab for HTLV-1-associated Myelopathy
Official Title
Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTLV-1-associated Myelopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Rituximab group Drug: Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused
Placebo Comparator: Control group Patients will receive usual care and drug use.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab group
Arm Type
Experimental
Arm Description
Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive usual care and drug use.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
A lower dosage of rituximab for HTLV-1-associated myelopathy
Primary Outcome Measure Information:
Title
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
Description
EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions
Time Frame
up to 360 days
Secondary Outcome Measure Information:
Title
Change in immunology function
Description
Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use
Time Frame
up to 360 days
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:
Age 18-80 years
Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
Exclusion Criteria:
Anticipated survival of at least 3 years
Inability to undergo neuroimaging with Magnetic Resonance
Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
Pregnancy
Malignancy (history of or active)
Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies
Facility Information:
Facility Name
Department of Neurology ,First Affiliated Hospital Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Fu, MD, PhD
Phone
13920263588
Email
fuying1995@163.com
First Name & Middle Initial & Last Name & Degree
Wan-Jian Chen, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Rituximab for HTLV-1-associated Myelopathy
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