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Mogamulizumab Q4week Dosing in Participants With R/R CTCL

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ClinicalTrials.gov Identifier: NCT04745234
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin, Inc.

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.

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma, Relapsed Cutaneous T-Cell Lymphoma Refractory Drug: Mogamulizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: 0761, KW0761, Poteligeo




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745234


Contacts
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Contact: Kyowa Kirin, Inc. 609-919-1100 kkd.clintrial.82@kyowakirin.com

Locations
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United States, Arizona
Mayo Clinic Arizona Not yet recruiting
Phoenix, Arizona, United States, 85054
United States, California
City of Hope National Medical Center Not yet recruiting
Duarte, California, United States, 91010
University of California Irvine Not yet recruiting
Irvine, California, United States, 92697
Stanford Cancer Center Not yet recruiting
Stanford, California, United States, 94304
United States, Connecticut
Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06520
United States, New York
New York Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10032
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
France
Hôpital Saint Louis Not yet recruiting
Paris, France
Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Not yet recruiting
Bologna, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino Not yet recruiting
Turin, Italy
Spain
Hospital del Mar Not yet recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain
United Kingdom
Queen Elizabeth Hospital Not yet recruiting
Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital Not yet recruiting
London, United Kingdom
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Kyowa Kirin, Inc.
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Responsible Party: Kyowa Kirin, Inc.
ClinicalTrials.gov Identifier: NCT04745234    
Other Study ID Numbers: 0761-016
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Mogamulizumab
Antineoplastic Agents