Mogamulizumab Q4week Dosing in Participants With R/R CTCL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04745234|
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : March 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-Cell Lymphoma, Relapsed Cutaneous T-Cell Lymphoma Refractory||Drug: Mogamulizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Current evidence of large cell transformation;
- Prior treatment with mogamulizumab;
- History of allogeneic transplant.
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
|Contact: Kyowa Kirin, Inc.||email@example.com|
|Responsible Party:||Kyowa Kirin, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases