Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objectives :

• To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,

• To determine the maximum tolerated dose of ATO.

Secondary objectives :

• Evaluation of the clinical and biological response of the SLE to ATO,

• Time of relapse in case of positive response,

• Determination of the efficacy,

• Pharmacokinetic study of ATO.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Medsenic Company
• Treatments: Arsenic Trioxide

Criteria

Inclusion Criteria:

• Systemic Lupus meeting the ACR (American College of Rheumatology) criteria, progressive either SLEDAI activity score ≥ 4, despite a corticosteroid therapy ≥ 10 mg / d associated with hydroxychloroquine (in the absence of contraindication or intolerance) and / or an immunosuppressive treatment at a stable dose,

• Insured,

• Availability for hospitalization required by the protocol (conventional and daily hospitalizations).

Exclusion Criteria:

• Inability to give their signed informed consent form,

• Performans status > 2

• QTcorrected space before treatment > 0.45 seconds

• Hemoglobin less than 11g/dL

• Neutrophils rate below 1 200 / mm3

• Platelets rate below 100 Giga / mm3

• Previous history of arrhythmia or heart rhythm disorder or other rhythm trouble by referring cardiologist

• Heart disorder (progressive pericarditis, valvular disease, ...) according to cardiologist

• Family previous history of arrhythmias

• Taking drugs that potentially prolong the QT

• Hypersensitivity to the active substance of Trisenox® or any of the excipients

• Serum potassium ≤ 4 milliequivalent / L

• Magnesemia ≤ 1,8 mg / dl

• Increase corticosteroids beyond 20 mg / day within 15 days before inclusion

• Immunosuppressive treatments, thalidomide introduced within the last 3 months

• Biotherapy (rituximab, belimumab, ...) introduced within 6 months prior to inclusion

• Pregnancy or lactation

• For women of childbearing age, men and their partner : unless effective contraception for the duration of participation in the study that is 7 months

• Creatinine clearance <50 ml / min,

• Hepatocellular insufficiency (TP <50%), and / or AST (aspartate aminotransferase) / ALT (alanine aminotransferase) / ALP (alkaline phosphatase) > 2N

• HBsAg positive, DNA detectable HbS

• Infection with HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)

• Renal or progressive central neurological impairment with possible alternative therapeutic (to be discussed with the principal investigator and scientific board meeting)

• Peripheral neuropathy

• Unweaned alcoholism

• Minor

• Patients older than 65 years

• Patient having been professionally exposed to arsenic (cleaning electronic circuits for example)

• Guardianship patients