Actively Recruiting
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
38
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
PharmaEssentia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable/progressive disease after at least two lines of topical therapy (Stage IIA-IIIB).
CONDITIONS
Official Title
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB, including Mycosis Fungoides, S�e9zary Syndrome, Lymphomatoid Papulosis, or other rare CTCL variants needing systemic treatment
- For Stage IA-IB: Failed at least two prior skin-directed therapies due to inadequate response, toxicity, or disease progression
- For Stage IIA-IIIB: Less than complete response to phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET), or failed disease after two or more lines of topical therapy
- Allowed to continue stable doses or less frequent schedules of phototherapy or ECP; no new or increased skin-directed therapies allowed during study
- Male or female aged 18 years or older
- No evidence of large cell transformation on skin biopsy at screening
- Able and willing to receive subcutaneous injections every two weeks
- Minimum 3-week washout after last systemic anti-cancer therapy before first dose
- Women of childbearing potential must have a negative pregnancy test within 7 days before medication and agree to reliable contraception during treatment and 8 weeks after
- Able to understand and sign informed consent
- Acceptable blood counts and thyroid function (normal or well-controlled)
- Lipid levels without severe hypertriglyceridemia or uncontrolled hypercholesterolemia
- Kidney function with eGFR at least 30 mL/min
- Liver enzymes within specified limits unless due to Gilbert's syndrome
You will not qualify if you...
- Large cell transformation at screening
- Child-Pugh B or C liver impairment
- Uncontrolled psychiatric disorders with PHQ-2 depression score 3 or higher
- Treatment with other investigational or systemic drugs within 3 weeks, except stable systemic steroids for erythroderma
- Severe or unstable cardiovascular disease including uncontrolled hypertension, heart failure NYHA class 2 or higher, serious arrhythmia, significant coronary artery disease, unstable angina, recent stroke or heart attack
- Active, uncontrolled HIV, HBV, or HCV infections (stable patients on therapy allowed)
- Active, uncontrolled serious eye disorders like severe retinopathy or glaucoma
- History or active serious autoimmune disease or use of systemic immunosuppressants
- History of solid organ or stem cell transplant
- Known allergy to interferons
- Baseline QTcF interval over 470 ms
- Active serious infections needing systemic antibiotics
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Richard Corona
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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