Mogamulizumab Q4week Dosing in Participants With R/R CTCL

  • STATUS
    Recruiting
  • End date
    Mar 22, 2024
  • participants needed
    33
  • sponsor
    Kyowa Kirin, Inc.
Updated on 22 August 2021

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.

Details
Condition Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory
Treatment Mogamulizumab
Clinical Study IdentifierNCT04745234
SponsorKyowa Kirin, Inc.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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