Mogamulizumab Q4week Dosing in Participants With R/R CTCL

a study on Cutaneous T-Cell Lymphoma Lymphoma T Cell Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

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.

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)

Keywords

Cutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory, Lymphoma, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Mogamulizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Current evidence of large cell transformation;
  • Prior treatment with mogamulizumab;
  • History of allogeneic transplant.

Locations

  • University of California Irvine accepting new patients
    Irvine California 92697 United States
  • Stanford Cancer Center accepting new patients
    Stanford California 94304 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kyowa Kirin, Inc.
ID
NCT04745234
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 33 study participants
Last Updated