Back to resultsMogamulizumab Q4week Dosing in Participants With R/R CTCL
Primary Purpose
Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mogamulizumab
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T-Cell Lymphoma, Relapsed
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.
Sites / Locations
- City of Hope National Medical Center
- University of California Irvine
- Stanford Cancer Center
- Tulane University School of Medicine
- New York Presbyterian Hospital
- University of Pittsburgh School of Medicine
- MD Anderson Cancer Center
- Hôpital Saint Louis
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Hospital del Mar
- Hospital Universitario 12 de Octubre
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario De Salamanca
- Queen Elizabeth Hospital
- Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mogamulizumab
Arm Description
Outcomes
Primary Outcome Measures
Number, percentage and severity of treatment emergent adverse events
Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04745234
Brief Title
Mogamulizumab Q4week Dosing in Participants With R/R CTCL
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mogamulizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mogamulizumab
Other Intervention Name(s)
0761, KW0761, Poteligeo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number, percentage and severity of treatment emergent adverse events
Description
Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).
Time Frame
From date of consent, at every treatment and follow up visit, up to 27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Turin
Country
Italy
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario De Salamanca
City
Salamanca
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
City
London
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Mogamulizumab Q4week Dosing in Participants With R/R CTCL
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