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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 other rare CTCL variants per WHO-EORTC classification, provided the investigator determines the disease course warrants systemic treatment.

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), b. Unacceptable toxicity, or c. Disease progression. Such patients require a systemic approach because of symptomatic, refractory, or recalcitrant disease. B) For 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.

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 schedule of the phototherapy or ECP. Patients are not allowed to start new skin-directed therapies or escalate the frequency of the prior skin-directed therapy schedule while on the study.

Male or female, aged 18 years or older.

Disqualifiers

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 agents, or immunotherapy. Concurrent use of systemic steroids is allowed in patients with erythroderma who have been on corticosteroids to avoid possible rebound flare of the disease, adrenal insufficiency, or unnecessary suffering. Concomitant phototherapy or extracorporeal photopheresis (ECP) are also allowed.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ropeginterferon alfa-2b

    Drug

    Will be administered via subcutaneous injection once every 2 weeks

Treatment groups

38 Participants
are divided into 4 treatment groups
Group A: Dose Level -2Experimental treatment 1 intervention
Group B: Dose Level -1Experimental treatment 1 intervention
Group C: Dose Level 1Experimental treatment 1 intervention
Group D: Expansion ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity

The percentage of participants who experience any grade 3 or higher non-hematologic toxicity and grade 4 or higher hematologic toxicity of P1101 according to CTCAE v5.0 during the first six weeks of therapy.

Time frame
6 weeks
2

Recommended Phase II Dose

The Recommended Phase II Dose will be determined according to the Bayesian optimal interval (BOIN) design.

Time frame
6 weeks

Secondary outcomes

1

Overall Response Rate

Proportion of patients who achieve a complete response or a partial response.

Time frame
1 year

Other outcomes

Sponsors and contacts

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