EUCTR2011-004151-39-NL进行中（未招募）1 期
Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) in Subjects with Previously Treated Peripheral T-cell Lymphoma (PTCL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed Written Informed Consent
- •1) Voluntarily signed and dated Ethics Committee (EC) approved informed consent form
- •in accordance with regulatory and institutional guidelines. Written informed consent
- •must be obtained prior to performing any study-related procedure;
- •Age and Sex
- •2) Males and female subjects = 18 years of age at the time of enrollment;
- •Target Population
- •3) Histologically confirmed diagnosis of PTCL according to World Health Organization
- •(2008) classification as specified below;66
- •a. PTCL-NOS;
- •c. Anaplastic large cell lymphoma (ALCL), ALK-positive;
- •d. ALCL, ALK-negative;
- •e. Transformed mycosis fungoides (MF).
- •4) Failed or intolerant of at least one prior systemic anticancer therapy;
- •5) Eastern Cooperative Oncology Group (ECOG) performance status score67 of = 2 at
- •study entry;
- •6) At least one site of disease measurable in two dimensions by computed
- •tomography(CT). Both nodal and extranodal disease will be considered (lymph nodes
- •must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and
- •short axis >1.0 cm).
- •7) Subjects who are positive for CCR4 by immunohistochemistry.
- •8) The subject has resolution of all clinically significant toxic effects of prior cancer
- •therapy to grade =1 by the National Cancer Institute Common Terminology Criteria
- •for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specifications
- •required in 9, 10, and 11 below;
- •9) Adequate hematological function:
- •a. absolute neutrophil count (ANC) = 1,500 cells/µL (= 1,500/mm3)
- •b. platelets = 100,000 cells/µL (= 100,000/mm3) or = 75,000 cells/µL
- •(= 75,000/mm3)in the presence of known bone marrow involvement.
- •Note: Retesting for values out of criteria will be permitted;
- •10) Adequate hepatic function:
- •a. bilirubin = 1.5 times the specific institutional upper limit of normal (ULN) except
- •for subjects with Gilbert’s Syndrome;
- •b. aspartate transaminase (AST) and alanine transaminase (ALT) each = 2.5 x ULN
- •or = 5.0 x ULN in the presence of known hepatic malignancy.
- •Note: Retesting for values out of criteria will be permitted;
- •11) Adequate renal function as evidenced by serum creatinine of < 1.5 x the ULN or a
- •calculated creatinine clearance of > 60 ml using the Cockroft-Gault formula.
- •Note: Retesting for values out of criteria will be permitted;
- •12)Women of childbearing potential (WOCBP) must have a negative pregnancy test
- •within 7 days of receiving study medication;
- •13) WOCBP 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 3 months after the last dose.
- •WOCBP 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);
- •14) Male subjects and their female partners of child bearing potential must be willing to
- 另有 4 项未显示
排除标准
- •1) Subject with the following PTCL diagnoses are excluded;
- •a. Precursor T/NK neoplasms;
- •b. Adult T-cell leukemia-lymphoma;
- •c. T-cell prolymphocytic leukemia;
- •d. T-cell large granular lymphocytic leukemia;
- •e. Aggressive NK-cell leukemia ;
- •f. Systemic EBV-positive T-cell lymphoproliferative disorder of childhood;
- •g. Hydroa vacciniforme-like lymphoma ;
- •h. Mycosis fungoides, other than transformed MF;
- •i. Sezary Syndrome;
- •j. Primary cutaneous CD30+ disorders: ALCL and lymphatoid papulosis;
- •k. Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell lymphoma;
- •l. Primary cutaneous CD4+ small/medium T-cell lymphoma;
- •m. Primary cutaneous gamma-delta T-cell lymphoma;
- •n. Extranodal NK /TT-cell lymphoma-nasal type;
- •o. Enteropathy-associated T-cell lymphoma;
- •p. Hepatosplenic T- cell lymphoma;
- •q. Subcutaneous panniculitis -like T-cell lymphoma;
- •r. Chronic lymphoproliferative disorder of NK cells.
- •2) Have had an invasive solid tumor malignancy in the past five years except nonmelanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or localized prostate cancer with a current prostate-specific antigen of < 0.1 ng/ml who is currently without evidence of
- •3) Relapsed less than 75 days of autologous stem cell transplant.
- •4) History of allogeneic stem cell transplant.
- •5) Evidence of central nervous system (CNS) metastasis.
- •6) Psychiatric illness, disability or social situation that would compromise the subject’s safety or ability to provide consent, or limit compliance with study requirements.
- •7) Subjects with a history of moderate or severe psoriasis (covering >3% body surface area) or with psoriasis associated with systemic symptoms e.g. arthropathy, or with a 1st degree relative with history of psoriasis that required medical intervention.
- •8) 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 New York Heart Association [NYHA] classification, see Appendix 1);
- •c. unstable angina pectoris;
- •d. angioplasty, stenting, or myocardial infarction within 6 months;
- •e. uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications;
- •f. clinically significant cardiac arrhythmia; or
- •g. uncontrolled diabetes.
- •9) Known or tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •10) Active herpes simplex or herpes zoster:
- •a. Subjects with a history of herpes zoster who have had an outbreak within the last 3 months will also be excluded;
- •b. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study.
- •11) Experienced allergic reactions to Mabs or other therapeutic proteins;
- •12) Known active autoimmune disease will be excluded (For example: Graves’ disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn’s disease);
- •13) Is pregnant (confirmed by beta-human chorionic gonadotrophin [ß-HCG]) or lactating
- •Prohibited Therapies and/or Medications
- •14) Prior treatment with KW-0761;
- •15) Initiation of treatment with systemic corticosteroids while on study is only permitted for acute and brief complications of underlying diseas
研究者
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已完成
2 期
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