EUCTR2011-004151-39-ES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)
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
- •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;
- •2)Males and female subjects = 18 years of age at the time of enrollment;
- •3)Histologically confirmed diagnosis of PTCL according to World Health
- •Organization (2008) classification as specified below;
- •a.PTCL-NOS
- •b.Angioimmunoblastic T-cell lymphoma
- •c.Anaplastic large cell lymphoma, ALK-positive
- •d.Anaplastic large cell lymphoma, ALK-negative
- •e.Transformed mycosis fungoides
- •4)Failed or intolerant of at least one prior systemic anticancer therapy;
- •5)Eastern Cooperative Oncology Group (ECOG) performance status score
- •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 (NCICTCAE,
- •v.4.0) excluding the specifications required in 9, 10, and 11
- •9)Adequate hematological function:
- •a.absolute neutrophil count (ANC) = 1,500/mm3;
- •b.platelets = 100,000 / mm3 or =75,000 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
- •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 based on the
- •Cockroft-Gault algorithm.
- •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
- •14) Male subjects and their female partners of child bearing potential
- •must be willing to
- 另有 10 项未显示
排除标准
- •1) Subject with the following PTCL diagnoses are excluded;
- •a.P recursor 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 mycosis fungoides
- •i. Sezary Syndrome
- •j. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma
- •and lymphatoid papulosis k.Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell
- •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 non-melanoma skin cancers, melanoma in situ, cervical
- •carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or
- •localized prostate cancer with a current PSA of = 0.1 ng/ml who is
- •currently without evidence of disease.
- •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
- •a. uncontrolled infection requiring antibiotics;
- •b. clinically significant cardiac disease (class III or IV of the New York
- •Heart Association [NYHA] classification, see Appendix 2);
- •c. unstable angina pectoris;
- •d. angioplasty, stenting, or myocardial infarction within 6 months;
- •e. uncontrolled hypertension (systolic blood pressure >160 mm Hg or
- •diastolic BP >100 mmHg, 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
- 另有 15 项未显示
研究者
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