Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Status unconfirmed · Phase 2

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

In brief

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.

Key facts

Study ID

NCT04745234

Run by

Kyowa Kirin, Inc.

People needed

34

Starts

2021-08-16

Expected to finish

2025-05-01

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of California Irvine — Irvine, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• New York Presbyterian Hospital — New York, New York, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Hôpital Saint Louis — Paris, France
• Azienda Ospedaliera Città della Salute e della Scienza di Torino — Turin, Italy
• Hospital del Mar — Barcelona, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
• Hospital Universitario De Salamanca — Salamanca, Spain
• Queen Elizabeth Hospital — Birmingham, United Kingdom
• Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital — London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.