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Clinical trial

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)

ID
Name
0761-016
Description
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.
Trial arms
Trial start
2021-08-16
Estimated PCD
2025-05-01
Trial end
2025-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Mogamulizumab
Other names:
0761, KW0761, Poteligeo
Size
34
Primary endpoint
Number, percentage and severity of treatment emergent adverse events
From date of consent, at every treatment and follow up visit, up to 27 months
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}
Updated at
2024-04-25

1 organization

1 product

3 indications

Organization
Kyowa Kirin
Product
Mogamulizumab
Indication
Cutaneous T-Cell Lymphoma
Indication
Relapsed
Indication
Cutaneous T-Cell Lymphoma Refractory