Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07047885
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cutaneous T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 27, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -2
    250 µg SQ every 2 weeks
  • Experimental: Dose Level -1
    350 µg SQ every 2 weeks
  • Experimental: Dose Level 1
    500 µg SQ every 2 weeks
  • Experimental: Expansion Arm
    Once the Recommended Phase 2 Dose (RP2D) is reached, an additional 20 participants will be treated at this dose for additional experience with safety and efficacy.

Primary Outcome Measure

Dose Limiting Toxicity [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Yumeng Zhang, MD (PRINCIPAL_INVESTIGATOR)
Celeste Bello, MD, MSPH (SUB_INVESTIGATOR)
Julio Chavez, MD, MS (SUB_INVESTIGATOR)
Sameh Gaballa, MD, MS (SUB_INVESTIGATOR)
Leidy Isenalumhe, MD, MS (SUB_INVESTIGATOR)
Bijal Shah, MD, MS (SUB_INVESTIGATOR)
Lubomir Sokol, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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