NCT04745234

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.

Trial Health

62
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach
5 countries

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

January 29, 2021

Last Update Submit

April 23, 2024

Conditions

Cutaneous T-Cell Lymphoma, RelapsedCutaneous T-Cell Lymphoma Refractory

Outcome Measures

Primary Outcomes (1)

  • 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).

    From date of consent, at every treatment and follow up visit, up to 27 months

Study Arms (1)

Mogamulizumab

EXPERIMENTAL
Drug: Mogamulizumab

Interventions

MogamulizumabDRUG

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.

Also known as: 0761, KW0761, Poteligeo
Mogamulizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

Stanford Cancer Center

Stanford, California, 94304, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hôpital Saint Louis

Paris, France

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Italy

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Universitario De Salamanca

Salamanca, Spain

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousRecurrence

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 9, 2021

Study Start

August 16, 2021

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)GB(3)FR(1)IT(1)US(7)