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New treatment option for Stage IB-IIB Cutaneous T-Cell Lymphoma
Official title 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
What this study is testing
What is Mogamulizumab?
Mogamulizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stage ib-iib cutaneous t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
- people 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...
- Males and female people ≥ 18 years
- WHO performance status 0-1
You likely can't join if
- 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...
- 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...
- History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
See the full eligibility criteria
Who can join
- Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
- people 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...
- Males and female people ≥ 18 years
- WHO performance status 0-1
- Adequate haematological and organ function:
- 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 people 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
- people 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...
- Male people 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...
- Female people 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
What rules you out
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Bordeaux, France
- Paris, France
- Mannheim, Germany
- Minden, Germany
- Athens, Greece
- Brescia, Italy
- Torino, Italy
- Barcelona, Spain
- Madrid, Spain
- Birmingham, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Bordeaux, France; Paris, France; Mannheim, Germany; Minden, Germany; Athens, Greece and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.