Study on Mogamulizumab for Treating Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Sponsor: Kyowa Kirin, Inc.
ClinicalTrials ID:NCT04745234
This clinical trial is testing the safety and tolerability of the drug mogamulizumab, given every four weeks, in adults with certain types of cutaneous T-cell lymphoma (CTCL) that have returned or not responded to previous treatments.
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Program Overview
This study is designed to evaluate how safe and tolerable the drug mogamulizumab is when given every four weeks to adults with relapsed or refractory mycosis fungoides (MF) and Sézary syndrome (SS), which are subtypes of cutaneous T-cell lymphoma (CTCL). Participants will first undergo a 28-day screening period to determine eligibility, followed by a treatment period that can last up to two years.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS).
- Be in stage IB, II-A, II-B, III, or IV of the disease.
- Have tried at least one previous systemic treatment, such as interferon, bexarotene, photopheresis, or chemotherapy. Note: Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic treatment.
Exclusion Criteria
- Have current evidence of large cell transformation.
- Have previously been treated with mogamulizumab.
- Have a history of receiving an allogeneic transplant.
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