Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Kyowa Kirin

Status and phase: Active, not recruiting; Phase 2

Conditions: Cutaneous T-Cell Lymphoma, Relapsed; Cutaneous T-Cell Lymphoma Refractory

Treatments: Drug: Mogamulizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04745234

0761-016

Details and patient eligibility

About

This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of MF or SS

  • Stage IB, II-A, II-B, III, or IV;

• Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.

Exclusion criteria

• Current evidence of large cell transformation;
• Prior treatment with mogamulizumab;
• History of allogeneic transplant.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Mogamulizumab

Experimental group

Treatment:

Drug: Mogamulizumab