Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Sponsor

Kyowa Kirin, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04745234

Collaborator

(none)

Enrollment

Locations

Arm

44.5

Anticipated Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma, Relapsed Cutaneous T-Cell Lymphoma Refractory	Drug: Mogamulizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Aug 16, 2021

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mogamulizumab	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 Names: 0761, KW0761, Poteligeo

Arm

Intervention/Treatment

Experimental: Mogamulizumab

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 Names:

0761, KW0761, Poteligeo

Outcome Measures

Primary Outcome Measures

Number, percentage and severity of treatment emergent adverse events [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14203
6	New York Presbyterian Hospital	New York	New York	United States	10032
7	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania	United States	15213
8	MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Hôpital Saint Louis	Paris		France
10	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin		Italy
11	Hospital del Mar	Barcelona		Spain
12	Hospital Universitario Vall d'Hebron - PPDS	Barcelona		Spain
13	Hospital Universitario 12 de Octubre	Madrid		Spain
14	Hospital Universitario Fundacion Jimenez Diaz	Madrid		Spain
15	Hospital Universitario De Salamanca	Salamanca		Spain
16	Queen Elizabeth Hospital	Birmingham		United Kingdom
17	Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital	London		United Kingdom
18	The Christie NHS Foundation Trust	Manchester		United Kingdom

Sponsors and Collaborators

Kyowa Kirin, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin, Inc.

ClinicalTrials.gov Identifier:

NCT04745234

Other Study ID Numbers:

0761-016

First Posted:

Feb 9, 2021

Last Update Posted:

Jul 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Mogamulizumab

Study Results

No Results Posted as of Jul 21, 2022