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Rituximab for HTLV-1-associated Myelopathy

Recruiting
18 - 80 years of age
Both
Phase 2

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Overview

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.

Eligibility

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

Study details

HTLV-1-associated Myelopathy

NCT04004819

First Affiliated Hospital of Fujian Medical University

27 January 2024

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