At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Mogamulizumab (drug), Total Skin Electron Beam Therapy (TSEB) (radiation), Mogamulizumab (subsequent cycles post TSEB) (drug)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- Mogamulizumab — drug: • Patients will receive mogamulizumab 1.0 mg/kg IV over at least 1 hour on Days 1, 8, 15 and 22 of the first 28 day treatment cycle (C1) and on Days 1 and 15 of subsequent 28 day cycle (C2). · Total Skin Electron Beam Therapy (TSEB) — radiation: * After completion of C2, patients will be administered TSEB at a dose of 12 Gy in 8 fractions (4 fractions per week). · Mogamulizumab (subsequent cycles post TSEB) — drug: • Mogamulizumab will be restarted at a dose of 1.0 mg/kg IV on Days 1, 8, 15 and 22 for cycle 3.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is for adults with stage IB to IIB mycosis fungoides, a type of skin lymphoma called cutaneous T-cell lymphoma, whose disease has come back or not responded to at least one earlier body-wide (systemic) treatment. It is run by the European Organisation for Research and Treatment of Cancer (EORTC) and is testing two treatments together: mogamulizumab, a man-made antibody that targets a protein called CCR4, and total skin electron beam therapy (TSEB), a type of radiotherapy that treats the whole skin surface.
Who can take part
- Adults aged 18 or over, both men and women
- Diagnosed with mycosis fungoides at stage IB, IIA or IIB that has never reached stage IIIA or higher
- The disease has come back (relapsed) or not responded (refractory) to at least one previous body-wide (systemic) treatment
- Any lasting side effects from earlier cancer treatment must have mostly settled (grade 1 or less), with some exceptions
- Able to carry out normal daily activity with little or no restriction (WHO performance status 0-1)
- Healthy enough blood, liver and kidney levels, checked with blood tests
- Normal heart function, checked with a heart trace (ECG) and a heart scan
- Able and willing to use effective contraception, or avoid sex, during the trial and for 6 months after the last dose
- Not breastfeeding, or willing to stop before the first dose and for 6 months after the last dose
- Written informed consent to take part
Who may not be able to
- Previous treatment with mogamulizumab or any other drug targeting CCR4
- Previous total skin electron beam therapy (TSEB)
- Radiotherapy to one area within 2 weeks before joining, or any systemic (body-wide) treatment for mycosis fungoides within 4 weeks before joining
- Another cancer in the past 5 years, apart from some fully treated early-stage cancers such as cervical, prostate, and some skin cancers
- Severe allergic reactions in the past to man-made antibodies or similar drugs, or allergy to any ingredient of mogamulizumab
- Serious uncontrolled health problems, such as infections needing antibiotics, significant heart disease, or a recent heart attack, stent or angioplasty (within 6 months)
- Active shingles (herpes zoster)
- Planned stem cell transplant
- History of HTLV-1 or HIV infection, or active hepatitis B or hepatitis C
- Conditions or circumstances that could affect taking part or following the trial plan
What taking part involves
- • Mogamulizumab, a man-made antibody given as a study drug; it targets a protein called CCR4
- • Total skin electron beam therapy (TSEB), a radiotherapy that treats the whole skin surface
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 43
- Started
- 2023-03-07
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for stage ib-iib cutaneous t-cell lymphoma
- • Phase2 - 43 participants
- • Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with stage ib-iib cutaneous t-cell lymphoma
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life. The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis. Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression; In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ in the criteria 'Adequate haematological and organ function' below
- ✓ a negative serum pregnancy test within 3 days
What the study is looking for
- ✓Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or...
- ✓Subjects who have failed (refractory or relapsed) at least one prior course of treatment that goes through your whole body.
- ✓Males and female subjects ≥ 18 years
- ✓WHO performance status 0-1
- ✓Adequate haematological and organ health:
Who cannot take part
- ✗Prior treatment with mogamulizumab, or any other anti-CCR4
- ✗Prior TSEB
- ✗Patients who received localised radiotherapy within 2 weeks prior to registration
- ✗Patients who received any treatment that goes through your whole body for MF within 4 weeks prior to registration.
- ✗History of other cancer in the past 5 years with the exception of treated carcinoma in situ of the cervix,...
See the full criteria
Where Is This Study? (2 UK sites)
University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre
Birmingham B15 2TH, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
EORTC EORTC HQ
Sponsor contactCONTACT
