Mogamulizumab Q4week Dosing in Participants With R/R CTCL

April 23, 2024 updated by: Kyowa Kirin, Inc.

Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hopital Saint Louis
  • Italy
      • Turin, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Irvine, California, United States, 92697
        • University of California Irvine
      • Stanford, California, United States, 94304
        • Stanford Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mogamulizumab
Drug: Mogamulizumab

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.

Other Names:
  • 0761, KW0761, Poteligeo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number, percentage and severity of treatment emergent adverse events
Time Frame: 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).
From date of consent, at every treatment and follow up visit, up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0761-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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