Rituximab for HTLV-1-associated Myelopathy

NCT04004819 | Unknown Phase 2

• 1 other identifier: MRCTA,ECFAHOFFMU[2019]142
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HTLV-1-associated Myelopathy

Outcome Measures

Primary Outcomes (1)

• 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

  up to 360 days

Secondary Outcomes (1)

• Change in immunology function

  up to 360 days

Study Arms (2)

Rituximab group

EXPERIMENTAL

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

Drug: Rituximab

Control group

NO INTERVENTION

Patients will receive usual care and drug use.

Interventions

Rituximab DRUG

A lower dosage of rituximab for HTLV-1-associated myelopathy

Rituximab group

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years
• Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Neurology ,First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Related Publications (1)

• Lv A, Fang Y, Lin X, Chen J, Song H, Wang N, Chen WJ, Fu Y, Li R, Lin Y. B-cell depletion limits HTLV-1-infected T-cell expansion and ameliorate HTLV-1-associated myelopathy. Ann Clin Transl Neurol. 2024 Oct;11(10):2756-2768. doi: 10.1002/acn3.52190. Epub 2024 Aug 26.

  PMID: 39186315 DERIVED

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; HTLV-I Infections; Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology department

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: August 15, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)