Actively Recruiting
Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-11-18
11
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
S
Seattle Genetics (now a wholly owned subsidiary of Pfizer)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
CONDITIONS
Official Title
Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health Centre, aged 18 years or older
- Worsening modified Rodnan Skin Score (mRSS) of 4 points or more compared to the score at the end of treatment visit (week 48) in the initial study
- Able to provide informed consent
You will not qualify if you...
- Poor lung function (FVC less than 40% and/or DLCO less than 30%)
- Pregnancy, breastfeeding, or childbearing potential without effective contraception (including partners for men in the study)
- Clinically significant pulmonary hypertension requiring treatment
- Significant heart disease
- Active or chronic infections needing systemic treatment
- HIV positive
- Active tuberculosis infection
- Active hepatitis B or C infection with viral replication
- Serious uncontrolled medical conditions including kidney, liver, pancreas, blood, digestive, hormone, lung, nervous system, brain, psychiatric diseases, or cancer
- Peripheral neuropathy Grade 2 or higher at screening
- Known or suspected allergy to treatment components
- Inability to follow study protocol due to alcoholism, drug dependency, or psychological disorder
- Laboratory abnormalities at screening: absolute neutrophil count less than 2.0 x 10^9/L, hemoglobin less than 85 g/L, platelet count less than 100 x 10^9/L, AST/SGOT or ALT/SGPT more than twice the upper normal limit
- Participation in another clinical trial within 6 weeks before randomization, except continuation from initial study BV201708
- Use of rituximab within previous 4 months
- Vaccination with live or attenuated vaccine less than 4 weeks before baseline visit
- Current or past progressive multifocal leukoencephalopathy (PML)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Actively Recruiting
Research Team
J
Janet E Pope, PhD
CONTACT
A
Amanda Philip
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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