OncoMatch/Clinical Trials/NCT07047885
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Is NCT07047885 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07047885 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy, investigational drug disqualifies patients from enrollment.
What disease stage is eligible?
Stage IA or IB or IIA or IIB or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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