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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 : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin, Inc.

Tracking Information
First Submitted Date  ICMJE January 29, 2021
First Posted Date  ICMJE February 9, 2021
Last Update Posted Date August 17, 2021
Actual Study Start Date  ICMJE August 16, 2021
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mogamulizumab Q4week Dosing in Participants With R/R CTCL
Official Title  ICMJE 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)
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cutaneous T-Cell Lymphoma, Relapsed
  • Cutaneous T-Cell Lymphoma Refractory
Intervention  ICMJE Drug: 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.

Other Name: 0761, KW0761, Poteligeo
Study Arms  ICMJE Experimental: Mogamulizumab
Intervention: Drug: Mogamulizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2021)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyowa Kirin, Inc. 609-919-1100 kkd.clintrial.82@kyowakirin.com
Listed Location Countries  ICMJE France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04745234
Other Study ID Numbers  ICMJE 0761-016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kyowa Kirin, Inc.
Study Sponsor  ICMJE Kyowa Kirin, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP