HTLV-1-associated MyelopathyPhase 2NCT04004819
Rituximab for HTLV-1-associated Myelopathy
A Phase 2 study testing Rituximab in people with HTLV-1-associated Myelopathy, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HTLV-1-associated Myelopathy
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology ,First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350005
Ying Fu, MD, PhD, 13920263588, fuying1995@163.com
Wan-Jian Chen, MD,PhD
About this study
Official title: Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy
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
- Being tested
- Rituximab
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
A lower dosage of rituximab for HTLV-1-associated myelopathy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Rituximab |
| Control group | No intervention | Patients will receive usual care and drug use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 360 days
Secondary outcomes (1)
Change in immunology function
Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use
Measured: up to 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start15 Aug 2019
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTLV-1-associated MyelopathyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004819
- Sponsor's protocol ID
- MRCTA,ECFAHOFFMU[2019]142
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39186315
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy
- ClinicalTrials.gov ID
- NCT04004819
- Acronym / sponsor ID
- MRCTA,ECFAHOFFMU[2019]142
- Conditions
- HTLV-1-associated Myelopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rituximab group | Experimental | Drug: RituximabRituximab 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 |
| Control group | No intervention | –Patients will receive usual care and drug use. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabA lower dosage of rituximab for HTLV-1-associated myelopathy | Drug | Rituximab group |
Primary outcome
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
Time frame: up to 360 days
EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions
1 secondary outcome
Change in immunology function
Time frame: up to 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 39186315Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Neurology ,First Affiliated Hospital Fujian Medical University
Fuzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with HTLV-1-associated Myelopathy, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment (time frame: up to 360 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.