Clinical trial NCT04745234: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma, Relapsed
Cutaneous T-Cell Lymphoma Refractory
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number, percentage and severity of treatment emergent adverse events
timeFrame: From date of consent, at every treatment and follow up visit, up to 27 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Paris
country: France
facility: Hôpital Saint Louis
city: Turin
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Salamanca
country: Spain
facility: Hospital Universitario De Salamanca
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: