OncoMatch/Clinical Trials/NCT07047885
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Is NCT07047885 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Ropeginterferon alfa-2b for cutaneous t cell lymphoma.
Treatment: Ropeginterferon alfa-2b — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage IA, IB, IIA, IIB, IIIA, IIIB
Prior therapy
Must have received: skin-directed therapy — 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), b. Unacceptable toxicity, or c. Disease progression.
Must have received: phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET) — Stage IIA-IIIB
Must have a documented less-than-complete response to phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET), or have failed disease after ≥2 lines of topical therapy (using the same definition of 'failed' as above).
Cannot have received: systemic anti-cancer therapy
Exception: ECP or phototherapy allowed
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.
Cannot have received: investigational drug
Treatment with another investigational drug or other systemic drug within 3 weeks.
Lab requirements
Blood counts
Acceptable Hematologic Parameters
Kidney function
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using a CKD EPI.
Liver function
AST/ALT < 3 x upper limit of normal (ULN), and total bilirubin < 2 x ULN (unless due to Gilbert's syndrome). Child-Pugh B or C hepatic impairment excluded.
Cardiac function
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 infarction) excluded. Baseline QTcF > 470 ms excluded.
Acceptable Hematologic Parameters. AST/ALT < 3 x upper limit of normal (ULN), and total bilirubin < 2 x ULN (unless due to Gilbert's syndrome). Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using a CKD EPI. 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 infarction) excluded. Baseline QTcF > 470 ms excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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