Status:
ACTIVE_NOT_RECRUITING
Mogamulizumab Q4week Dosing in Participants With R/R CTCL
Lead Sponsor:
Kyowa Kirin, Inc.
Conditions:
Cutaneous T-Cell Lymphoma, Relapsed
Cutaneous T-Cell Lymphoma Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 M...
Eligibility Criteria
Inclusion
- 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
- Current evidence of large cell transformation;
- Prior treatment with mogamulizumab;
- History of allogeneic transplant.
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04745234
Start Date
August 16 2021
End Date
May 1 2025
Last Update
April 25 2024
Active Locations (16)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California Irvine
Irvine, California, United States, 92697
3
Stanford Cancer Center
Stanford, California, United States, 94304
4
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112