A clinical trial to assess the safety of mogamulizumab given every 4 weeks in patients with cutaneous T-cell lymphoma that has reappeared or has not responded to treatment.
- Conditions
- Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL) - Mycosis fungoides and Sezary syndromeMedDRA version: 22.0Level: LLTClassification code 10028510Term: Mycosis fungoides/Sezary syndrome recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004537-20-FR
- Lead Sponsor
- Kyowa Kirin Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 33
1) Voluntarily signed and dated institutional review board (IRB)/ ethics committee (EC) approved informed consent obtained prior to performing any study-related procedur in accordance with regulatory and institutional guidelines.
2) Male and female participants equal to or more than 18 years of age at the Pre-treatment Visit.
3) Histologically confirmed diagnosis of MF or SS.
- Stage IB, II-A, II-B, III, or IV (Olsen, 2011);
4) Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus UVA is not considered a systemic therapy.
5) ECOG performance status score of = 1.
6) The participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade = 1 according to NCI-CTCAE (v.5.0), excluding the specifications required in 7, 8, and 9 below.
7) Adequate hematological function, defined as:
a) Absolute neutrophil count (ANC) = 1000 cells/uL (= 1000/mm3) and
b) Platelets =75,000 cells/uL (=75,000/mm3);
8) Adequate hepatic function, defined as:
a) Bilirubin = 1.5 times the specific institutional upper limit of normal (ULN), except for participants with Gilbert’s syndrome.
b) Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) each = 2.5 × ULN or = 5.0 × ULN in the presence of known hepatic involvement by CTCL.
9) Adequate renal function, defined as calculated creatinine clearance = 30 mL/min using the Cockcroft-Gault formula.
10) Participants previously treated with anti-CD4 antibody or alemtuzumab are eligible, provided their CD4+ cell counts are = 200/mm3.
11) Participants with MF and a known history of non-complicated staphylococcus colonization/infection are eligible, provided they continue to receive stable doses of prophylactic antibiotics.
12) Women of childbearing potential must have a negative pregnancy test within 7 days prior to receiving study medication.
13) Women of childbearing potential must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true 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.
• Women of childbearing potential includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea = 12 consecutive months without an alternative medical cause).
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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
1) Current evidence of large cell transformation (LCT). Participants with clinical features suggestive of LCT must have a biopsy performed within 4 months prior to Cycle 1 Day 1 to rule out transformed disease. Participants with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in
skin or lymph nodes would be eligible.
2) Diagnosed with another malignancy in the past 2 years. However, participants with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current prostate-specific antigen of < 0.1 ng/mL, treated thyroid cancer, or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past 2 years may enroll as long as there is no current evidence of disease.
3) Clinical evidence of central nervous system (CNS) metastasis.
4) Psychiatric illness, disability, or social situation that would compromise the participant’s safety or ability to provide consent, or limit compliance with study requirements.
5) Significant uncontrolled intercurrent illness including, but not limited to:
a) uncontrolled infection requiring antibiotics;
b) clinically significant cardiac disease (class III or IV of the NYHA classification);
c) unstable angina pectoris;
d) angioplasty, stenting, or myocardial infarction within 6 months;
e) uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg, found on 2 consecutive measurements separated by a 1-week period) despite the use of 2 anti-hypertensive medications;
f) clinically significant cardiac arrhythmia; or
g) uncontrolled diabetes.
6) Active human immunodeficiency virus (HIV), human T-cell lymphotropic virus, type 1, hepatitis B, or hepatitis C disease.
7) Active herpes simplex or herpes zoster. Participants on prophylaxis for herpes may enter the study and should continue to take the prescribed medication for the duration of the study if they started taking medication at least 30 days prior to the Pre-treatment Visit, have no signs of active infection, and their last active infection
was more than 6 months ago.
8) Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
9) Known active autoimmune disease (i.e., Graves’ disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn’s disease; psoriasis).
10) Is pregnant (confirmed by beta human chorionic gonadotropin) or lactating.
11) Prior treatment with mogamulizumab.
12) Have had any therapy directed against the participant’s underlying cancer or any investigational medications within 4 weeks of randomization (skin directed treatments, including topicals and radiation within 2 weeks of randomization).
However, participants with rapidly progressive malignant disease may be enrolled prior to this period after discussion with and approval from the Medical Monitor.
13) Participants on a stable dose of a low dose systemic corticosteroid (= 20 mg prednisone equivalent) for at least 4 weeks prior to the Pre-treatment Visit may continue use, although the Investigator should attempt to taper the use to the lowest dosage tolerable while on study. Initiation of treatment with systemic corticosteroids or increase in dose while on study is not permitted except to treat an infusion reaction. Participants may receive intra-articular corticosteroid injections, intraocular corticosteroid drops, inhalation or nasal corticosteroids, and replacement doses of systemic corticosteroids as needed.
14)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method