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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 : March 3, 2023
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 : May 2025
Estimated Study Completion Date : May 2025

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

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

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

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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: March 3, 2023
Last Verified: March 2023
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, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents