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
Apply to this trial

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

First listed
Jul 2, 2025
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)

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FL

Related Studies