Phase II study of a monoclonal antibody, mogamulizumab, associated with radiotherapy called total skin electron beam (TSEB), in patients with cutaneous T-cell lymphoma

Open-Label, phase II, Multi-Center, study of Anti-CCR4 Monoclonal Antibody (mogamulizumab) Plus Total Skin Electron Beam therapy (TSEB) in patients with stage IB-IIB Cutaneous T-Cell Lymphoma - MOGAT

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004566-17-IT

Enrollment

Registered

2021-08-30

Start date

2021-11-08

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-cell lymphoma (Mycosis Fungoides (MF) and Sézary Syndrome (SS))

Interventions

Trade Name: POTELIGEO Product Name: KW-0761 (Mogamulizumab) Product Code: [KW-0761] Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Mogamulizumab CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Males and female subjects = 18 years; • Mycosis fungoides stage IB, IIA, IIB; • Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy; • Adequate haematological and organ function; • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: • Prior treatment with mogamulizumab; • Prior TSEB

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria) of anti-CCR4 monoclonal antibody (mogamulizumab) and TSEB in IB-IIB cutaneous T-cell lymphoma. ;Secondary Objective: • To evaluate the overall safety • To assess the response rate • To assess the progression-free survival • To assess the overall survival • To assess the time to progression • To evaluate the duration of response • To evaluate the time to next significant treatment;Primary end point(s): Progression Free Survival Rate at 48 weeks (PFSR-48);Timepoint(s) of evaluation of this end point: Up to 48 weeks after start of mogamulizumab for each patient	—

Measure

Time frame

Main Objective: To evaluate the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria) of anti-CCR4 monoclonal antibody (mogamulizumab) and TSEB in IB-IIB cutaneous T-cell lymphoma. ;Secondary Objective: • To evaluate the overall safety • To assess the response rate • To assess the progression-free survival • To assess the overall survival • To assess the time to progression • To evaluate the duration of response • To evaluate the time to next significant treatment;Primary end point(s): Progression Free Survival Rate at 48 weeks (PFSR-48);Timepoint(s) of evaluation of this end point: Up to 48 weeks after start of mogamulizumab for each patient

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Secondary

Measure	Time frame
Secondary end point(s): • Overall safety of both mogamulizumab and TSEB; • Response rate (RR) to both mogamulizumab and TSEB ; • Progression-free survival (PFS) ; • Overall survival (OS); • Time to progression ; • Duration of response ; • Time to next treatment. Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.;Timepoint(s) of evaluation of this end point: • Overall safety: 48 months after last patient in; • RR: from the first patient treatment start till 48 weeks as of last patient in; • PFS: from the first patient treatment start till 48 weeks as of last patient in; • OS: from the first patient treatment start till 5 years after last patient treatment; • Time to progression: from the first patient treatment start till 48 weeks as of last patient in; • Duration of resp: from the first patient treatment start till 48 weeks as of last patient in; • Time to next treatment: from the first patient treatment start till 48 weeks as of last patient in.	—

Measure

Time frame

Secondary end point(s): • Overall safety of both mogamulizumab and TSEB; • Response rate (RR) to both mogamulizumab and TSEB ; • Progression-free survival (PFS) ; • Overall survival (OS); • Time to progression ; • Duration of response ; • Time to next treatment. Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.;Timepoint(s) of evaluation of this end point: • Overall safety: 48 months after last patient in; • RR: from the first patient treatment start till 48 weeks as of last patient in; • PFS: from the first patient treatment start till 48 weeks as of last patient in; • OS: from the first patient treatment start till 5 years after last patient treatment; • Time to progression: from the first patient treatment start till 48 weeks as of last patient in; • Duration of resp: from the first patient treatment start till 48 weeks as of last patient in; • Time to next treatment: from the first patient treatment start till 48 weeks as of last patient in.

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Countries

Finland, France, Germany, Greece, Italy, Spain, United Kingdom

Contacts

Public ContactRegulatory Affairs Department

European Organisation for the Research and Treatment of Cancer

regulatory@eortc.org+3227727063

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026