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New treatment option for Cutaneous T Cell Lymphoma
Official title Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
ClinicalTrials.gov ID: NCT07047885
What this study is testing
What is Ropeginterferon alfa-2b?
Ropeginterferon alfa-2b is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cutaneous t cell lymphoma.
Also referred to as P1101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis...
- A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where "failed" is defined as any of the following: a...
- Patients are allowed to continue phototherapy or ECP at their prior schedule or a less frequent schedule. Topical therapy, phototherapy, and ECP are...
- Male or female, aged 18 years or older.
- There is no evidence of large cell transformation on the skin biopsy at the screening visit.
You likely can't join if
- Large cell transformation at screening visit.
- Child-Pugh B or C hepatic impairment of any etiology.
- Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3.
- Treatment with another investigational drug or other systemic drug within 3 weeks. Concomitant administration of radiotherapy or systemic anti-cancer...
- Severe or unstable cardiovascular disease (uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant...
- Active, uncontrolled HIV, detectable HBV, or active HCV infection. The patients who are stable on anti-retroviral therapy or suppressed on HBV/HCV...
See the full eligibility criteria
- Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis Fungoides (MF); Sézary Syndrome (SS); Lymphomatoid Papulosis (LyP) or...
- A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where "failed" is defined as any of the following: a. Inadequate response (persistent clinically significant lesions or symptoms)...
- Patients are allowed to continue phototherapy or ECP at their prior schedule or a less frequent schedule. Topical therapy, phototherapy, and ECP are allowed if the patient has been on a stable dose of topical therapy or...
- Male or female, aged 18 years or older.
- There is no evidence of large cell transformation on the skin biopsy at the screening visit.
- Ability to take subcutaneous injection medication and be willing to adhere to the P1101 q2week injection regimen.
- Minimum wash-out period of 3 weeks between the last dose of prior systemic therapy (other anti-cancer therapy aside from ECP or phototherapy) and the first dose of P1101.
- Women of childbearing potential (WCBP) must have a negative serum beta-HCG pregnancy test within 7 days of receiving study medication. An WOCP is considered a sexually mature female who: 1) has not undergone a...
- Ability to understand and the willingness to sign a written informed consent document.
- Acceptable Hematologic Parameters
- Thyroid-stimulating hormone (TSH) within institutional normal limits OR well-controlled on thyroid replacement.
- Lipid Panel: a. No severe hypertriglyceridemia (e.g., triglycerides \< 400-500 mg/dL, or medically manageable per investigator discretion). b. No uncontrolled hypercholesterolemia that is unresponsive to standard lipid...
- Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using a CKD EPI.
- AST/ALT \< 3 x upper limit of normal (ULN), and total bilirubin \< 2 x ULN (unless due to Gilbert's syndrome).
- Large cell transformation at screening visit.
- Child-Pugh B or C hepatic impairment of any etiology.
- Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3.
- Treatment with another investigational drug or other systemic drug within 3 weeks. Concomitant administration of radiotherapy or systemic anti-cancer therapy, including but not restricted to chemotherapy, biological...
- Severe or unstable cardiovascular disease (uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina, or recent stroke or myocardial...
- Active, uncontrolled HIV, detectable HBV, or active HCV infection. The patients who are stable on anti-retroviral therapy or suppressed on HBV/HCV therapy are allowed in the study.
- Active, uncontrolled ophthalmic disorders such as severe retinopathy, uncontrolled glaucoma, or advanced proliferative retinopathy.
- History of or active serious or uncontrolled autoimmune disease, or patients on systemic immunosuppressants or history of systemic immunosuppressants for autoimmune disease.
- History of solid organ or stem cell transplantation recipients who are at heightened risk for immunologic complications on interferons.
- Known hypersensitivity to interferons.
- Baseline QTcF \> 470 ms.
- No active, serious infection requiring systemic antimicrobial therapy at screening.
- Pregnant or breastfeeding women are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.