Stage IB-IIB Cutaneous T-Cell LymphomaPhase 2MOGATNCT04128072
Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
A Phase 2 study testing Mogamulizumab, Total Skin Electron Beam Therapy (TSEB) and Mogamulizumab (subsequent cycles post TSEB) in people with Stage IB-IIB Cutaneous T-Cell Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IB-IIB Cutaneous T-Cell Lymphoma
- What is being tested?
- Mogamulizumab, Total Skin Electron Beam Therapy (TSEB) and Mogamulizumab (subsequent cycles post TSEB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 7 Mar 2023to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
- Subjects who have failed (refractory or relapsed) at least one prior course of systemic therapy.
- All clinically significant toxic effects of prior cancer therapy to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE, v.5.0), excluding the specifications required in the criteria 'Adequate haematological and organ function' below
- Males and female subjects ≥ 18 years
- WHO performance status 0-1
- Adequate haematological and organ function:
Show all 18Show fewer
- absolute neutrophil count (ANC) ≥ 1.0 × 109/L
- platelets ≥ 75 × 109/L (≥ 75,000/mm3)
- bilirubin ≤ 1.5 × upper limit of normal (ULN) except for subjects with Gilbert's syndrome;
- aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN
- serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance > 50 mL/min using the Cockcroft-Gault formula
- Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided a washout period ≥ 3 months and CD4+ cell counts ≥ 200/mm3
- Clinically normal cardiac function based on 12-lead ECG and above the institutional lower limit of normal for left ventricular ejection fraction assessed either by multi-gated acquisition scan or cardiac ultrasound
- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the first dose of study treatment
- WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse during the study and for 6 months after the last dose.
- Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 6 months after the last dose.
- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Who cannot join
- 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 systemic therapy for MF within 4 weeks prior to registration.
- Note: In case of rapid progression, if patient has recovered from all toxicities AND last dose occurred more than 5 half lives of the drug/treatment used, patient could be allowed to start earlier after consultation with medical monitor
- History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix, localized prostate cancer with PSA <0.1, in-situ melanoma, and non-melanoma skin cancer
Show all 30Show fewer
- History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
- Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation (see section 6.1.1)
- Significant uncontrolled intercurrent illness including, but not limited to:
- uncontrolled infection requiring antibiotics;
- clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification);
- unstable angina pectoris;
- angioplasty, stenting, or myocardial infarction within 6 months;
- clinically significant cardiac arrhythmia
- Have active sign of herpes zoster
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
- Patients with eczema, psoriasis, lichen simplex chronicus, with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- Rash must cover <10% of body surface area
- Disease is well controlled at baseline and requires stable use of low to mild potency topical corticosteroids for at least 4 weeks.
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 4 months.
- Immunomodulatory drugs or high-dose systemic steroids for concomitant or intercurrent conditions other than T-cell lymphoma within 7 days of registration.
- However, stable dose of a low dose systemic systemic corticosteroid (≤10 mg prednisone equivalent per day) or stable dose of a low potency topical corticosteroid for at least 4 weeks prior to the registration is permitted. Subjects may receive intra-articular, intraocular, inhalation or nasal corticosteroids. Initiation of treatment with corticosteroids or increase in dose while on study is not permitted except for the treatment of adverse events.
- Patients who are planned to receive stem cell transplantation
- Has a known history of Human T-lymphotropic virus 1 (HTLV-1), or human immunodeficiency virus (HIV) (test to be performed within 21 days of registration if allowed by local legislation)
- Has known active Hepatitis B or Hepatitis C
- Note: patient will be eligible if:
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening . The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041
- Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
- Recruiting
Hospital Universitario Puerta De Hierro
Madrid, 28222
France2 sites, 2 recruiting
- Recruiting
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
Bordeaux, 33075
- Recruiting
Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, 75010
Germany2 sites, 2 recruiting
- Recruiting
UniversitaetsMedizin Mannheim
Mannheim, 68167
- Recruiting
Muehlenkreiskliniken Johannes Wesling Klinikum Minden
Minden, 32429
Italy2 sites, 2 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro
Torino, 10126
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre
Birmingham, B15 2TH
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Denmark1 site, 1 recruiting
- Recruiting
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, 2100
Greece1 site, 1 recruiting
- Recruiting
Athens University - Attikon University General Hospital
Athens, 12462
About this study
Official title: MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
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.
Read more
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.
- Conditions
- Stage IB-IIB Cutaneous T-Cell Lymphoma
- Being tested
- Mogamulizumab, Total Skin Electron Beam Therapy (TSEB), Mogamulizumab (subsequent cycles post TSEB)
- Keywords
- Cutaneous T-Cell Lymphoma, Mogamulizumab, Total Skin Electron Beam therapy
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabDrug
- 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). TSEB will start 28 days (window of + 7 days) after mogamulizumab (C2 D1).
- In case of toxicity from mogamulizumab, the maximum delay permitted for the start of TSEB is 2 weeks.
- If recovery to at least grade 1 from toxicity exceeds the 2 weeks interval, please contact the medical monitor.
- Mogamulizumab is stopped during TSEB administration.
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. Subsequent cycles will be administered as for C2.
Treatment with mogamulizumab will be continued until disease progression (PD) or the occurrence of another withdrawal criterion.
| Study group | Role | What they receive |
|---|---|---|
| Mogamulizumab + Total Skin Electron Beam Therapy (TSEB) | Experimental | Treatment with mogamulizumab will be continued until disease progression or the occurrence of another withdrawal criterion as specified in the protocol.
TSEB will start 28 days after mogamulizumab cycle 2 day 1 at a dose of 12 Gy in 8 fractions over two weeks (4 fractions per week). Receives: Drug: Mogamulizumab; Radiation: Total Skin Electron Beam Therapy (TSEB); Drug: Mogamulizumab (subsequent cycles post TSEB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate at 48 weeks
The primary endpoint is the progression free survival rate, assessed at 48 weeks after start of mogamulizumab
Measured: Up to 48 weeks after start of mogamulizumab for each patient
Secondary outcomes (7)
Occurrence of Adverse Events
Measured: 48 months after last patient in
Response rate to both mogamulizumab and TSEB
Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria
Measured: From the first patient treatment start till 48 weeks as of last patient in
Progression-free survival
From start of mogamulizumab to the first date of progressive disease or death from any cause
Measured: From the first patient treatment start till 48 weeks as of last patient in
Overall survival
Start of mogamulizumab till the date of death from any cause
Measured: From the first patient treatment start till 5 years after last patient treatment
Time to progression
From start of mogamulizumab to the date of first documentation of progressive disease or death due to progressive disease, whichever occurs first
Measured: From the first patient treatment start till 48 weeks as of last patient in
Duration of response
Duration of response will be measured for patients achieving a partial response or complete response are first met until the first date that recurrent or progressive disease
Measured: From the first patient treatment start till 48 weeks as of last patient in
Time to next treatment
From time from initiation of mogamulizumab until the time the initiation of any total skin-equivalent treatment (topical treatment to >50% of body surface, phototherapy, second TSEB) or systemic treatment is recorded
Measured: From the first patient treatment start till 48 weeks as of last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start7 Mar 2023
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB-IIB Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pablo Luis Ortiz Romero, Principal investigator, Hospital Universitario 12 De Octubre,Madrid, SpainRichard Cowan, Principal investigator, The Christie NHS Foundation Trust Manchester, UKJan Nicolay, Principal investigator, UniversitaetsMedizin Mannheim, Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128072
- Sponsor's protocol ID
- EORTC-1820-CLTF
- Acronym
- MOGAT
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04128072
- Acronym / sponsor ID
- MOGAT / EORTC-1820-CLTF
- Conditions
- Stage IB-IIB Cutaneous T-Cell Lymphoma
- Keywords
- Cutaneous T-Cell Lymphoma, Mogamulizumab, Total Skin Electron Beam therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mogamulizumab + Total Skin Electron Beam Therapy (TSEB) | Experimental | Drug: Mogamulizumab, Radiation: Total Skin Electron Beam Therapy (TSEB), Drug: Mogamulizumab (subsequent cycles post TSEB)Treatment with mogamulizumab will be continued until disease progression or the occurrence of another withdrawal criterion as specified in the protocol. TSEB will start 28 days after mogamulizumab cycle 2 day 1 at a dose of 12 Gy in 8 fractions over two weeks (4 fractions per week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
- Subjects who have failed (refractory or relapsed) at least one prior course of systemic therapy.
- All clinically significant toxic effects of prior cancer therapy to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE, v.5.0), excluding the specifications required in the criteria 'Adequate haematological and organ function' below
- Males and female subjects ≥ 18 years
- WHO performance status 0-1
Key exclusion criteria (30 listed)
- 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 systemic therapy for MF within 4 weeks prior to registration.
- Note: In case of rapid progression, if patient has recovered from all toxicities AND last dose occurred more than 5 half lives of the drug/treatment used, patient could be allowed to start earlier after consultation with medical monitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mogamulizumab• 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). | Drug | Mogamulizumab + Total Skin Electron Beam Therapy (TSEB) |
| Total Skin Electron Beam Therapy (TSEB)* After completion of C2, patients will be administered TSEB at a dose of 12 Gy in 8 fractions (4 fractions per week). TSEB will start 28 days (window of + 7 days) after mogamulizumab (C2 D1). * In case of toxicity from mogamulizumab, the maximum delay permitted for the start of TSEB is 2 weeks. * If recovery to at least grade 1 from toxicity exceeds the 2 weeks interval, please contact the medical monitor. * Mogamulizumab is stopped during TSEB administration. | Radiation | Mogamulizumab + Total Skin Electron Beam Therapy (TSEB) |
| Mogamulizumab (subsequent cycles post TSEB)• Mogamulizumab will be restarted at a dose of 1.0 mg/kg IV on Days 1, 8, 15 and 22 for cycle 3. Subsequent cycles will be administered as for C2. Treatment with mogamulizumab will be continued until disease progression (PD) or the occurrence of another withdrawal criterion. | Drug | Mogamulizumab + Total Skin Electron Beam Therapy (TSEB) |
Primary outcome
Progression Free Survival Rate at 48 weeks
Time frame: Up to 48 weeks after start of mogamulizumab for each patient
The primary endpoint is the progression free survival rate, assessed at 48 weeks after start of mogamulizumab
7 secondary outcomes
Occurrence of Adverse Events
Time frame: 48 months after last patient in
Response rate to both mogamulizumab and TSEB
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Progression-free survival
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Overall survival
Time frame: From the first patient treatment start till 5 years after last patient treatment
Time to progression
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Duration of response
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Time to next treatment
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Related trials for Stage IB-IIB Cutaneous T-Cell Lymphoma
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Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
RecruitingPhase 2
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Luis Ortiz Romero principal investigator
Hospital Universitario 12 De Octubre,Madrid, Spain
Richard Cowan principal investigator
The Christie NHS Foundation Trust Manchester, UK
Jan Nicolay principal investigator
UniversitaetsMedizin Mannheim, Mannheim, Germany
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mogamulizumab, Total Skin Electron Beam Therapy (TSEB) and Mogamulizumab (subsequent cycles post TSEB) in people with Stage IB-IIB Cutaneous T-Cell Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, France, Germany, Italy, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EORTC EORTC HQ (+32 2 774 1611, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Rate at 48 weeks (time frame: Up to 48 weeks after start of mogamulizumab for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.