Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Conditions

Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory

Brief summary

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.

Julia Scarisbrick, Christiane Querfeld, Oleg E. Akilov, Martine Bagot, Raúl Córdoba et al. (22 authors)

Blood2025-11-03

10.1182/blood-2025-1875

Mogamulizumab in Patients with Mycosis Fungoides/Sézary Syndrome: Preliminary Results from an Ongoing Phase 2, Open-Label, Multicenter, Single-Arm Study Assessing a 4-Weekly Dosing Schedule

Christiane Querfeld, Julia Scarisbrick, Oleg E. Akilov, Payal Arora, Yi Liu et al. (22 authors)

Blood2024-11-05

10.1182/blood-2024-200596

Rationale for the Clinical Use of Less Frequent Dosing of Mogamulizumab for T-Cell Lymphomas Using Population Pharmacokinetic and Exposure Response Analysis

Krina Mehta, Dimple Patel, Ragini Vuppugalla, Alina Tudor, Karen M. Dwyer et al. (7 authors)

Blood2021-11-05

10.1182/blood-2021-148099

443 Open-label, phase 2 study to assess the safety of mogamulizumab at 2 mg/kg Q4W maintenance dosing in patients with relapsed/refractory MF/SS subtypes of CTCL

Karen M. Dwyer, Roland Meier, Matthew Hruska, Floyd E. Fox, Takahiro Ito

Regular and Young Investigator Award Abstracts2021-11-01

10.1136/jitc-2021-sitc2021.443

Interventions

DRUGMogamulizumab

For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-μm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22. For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Number, percentage and severity of treatment emergent adverse events	From date of consent, at every treatment and follow up visit, up to 27 months	Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).

Countries

France, Italy, Spain, United Kingdom, United States

Outcome results

None listed