Rituximab for HTLV-1-associated Myelopathy

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 2

Conditions: HTLV-1-associated Myelopathy

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04004819

MRCTA,ECFAHOFFMU[2019]142

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Rituximab group

Experimental group

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

Treatment:

Drug: Rituximab

Control group

No Intervention group

Description:

Patients will receive usual care and drug use.