KCT0012239进行中（未招募）2 期
Multicenter, open label, phase II study of Azacitidine-LEnalidomide for patients with Relapsed or refractory T-cell lymphoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •Patients diagnosed with mature T-cell lymphoma of T-cell origin according to the 2016 WHO diagnostic criteria who have experienced at least one relapse or refractory state
- •? Angioimmunoblastic T-cell lymphoma
- •? Follicular helper T-cell lymphoma
- •? Peripheral T-cell lymphoma with follicular helper T-cell type
- •? Peripheral T-cell lymphoma, not otherwise specified
- •? Hepatosplenic T-cell lymphoma
- •Age 20–90 at the time of diagnosis
- •ECOG activity 0–2
- •Presence of one or more measurable lesions (long axis 1.5 cm or larger) (however, for hepatosplenic T-cell lymphoma, enrollment is possible if hepatomegaly or splenomegaly is above the normal range or if invasion is confirmed by bone marrow biopsy)
- •Cardiac function adequate for chemotherapy: LVEF = 45% on echocardiography or MUGA
- •Renal function adequate: Serum Cr = 1.5 mg/dL or creatinine clearance according to the Cockcroft-Gault formula = 50 mL
- •Adequate liver function: ALT = 2.5 times the upper limit of normal (however, if liver involvement is present, = 5 times the upper limit of normal), Total bilirubin = 2 times the upper limit of normal (however, if liver involvement is present, = 3 times the upper limit of normal)
- •Adequate hematological findings: Absolute neutrophil count = 1,500/µL, Platelets = 100,000/µL (however, if bone marrow involvement is present, Absolute neutrophil count = 500/µL, Platelets = 50,000/µL)
- •Written consent to the clinical trial participation consent form
- •Ability to comply with the trial visit schedule and other requirements of the protocol
- •For women of childbearing age, a negative pregnancy test result
- •Women of childbearing age must use an effective method of contraception (i.e., hormonal contraceptives, intrauterine devices, spermicide-assisted diaphragms, spermicide-assisted condoms, or abstinence) during the clinical trial period and for 3 months thereafter; men must use an effective method of contraception during the clinical trial period and for 3 months thereafter.
- •Life expectancy = 90 days (3 months)
- •Hepatitis B or C clinical trial subjects: Hepatitis B carriers taking prophylactic antivirals may be selected, and subjects with inactive Hepatitis C (normal aminotransferase) may also be selected.
排除标准
- •Non-Hodgkin lymphoma of a different specific subtype
- •History of receiving chemotherapy for Hodgkin or other non-Hodgkin lymphoma within the last 5 years
- •History of being diagnosed with active cancer within the last 3 years. (However, completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer can be registered)
- •Uncontrolled Hepatitis B (however, asymptomatic HBsAg-positive or anti-HBc Ab-positive individuals receiving prophylactic antiviral therapy such as entecavir or tenofovir are eligible for enrollment)
- •History of chronic Hepatitis C (however, if HCV IgG-positive, enrollment is eligible if the HCV-RNA quantitative test is negative)
- •History of human immunodeficiency virus (HIV) infection
- •Severe disease or medical condition
- •Congestive heart failure = NYHA class 3
- •Acute coronary syndrome (newly onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months of study enrollment
- •History of major neurological or psychiatric disease, including dementia or epilepsy
- •Severe chronic obstructive pulmonary disease with hypoxemia
- •Cerebrovascular disease (including transient cerebral ischemia) within 3 months of study enrollment
- •Non-healing wounds, ulcers, or bone fractures
- •Uncontrolled active infection (viral, bacterial, or fungal infection)
- •Concomitant administration of other investigational agents currently in clinical trials
- •Previous history of hypersensitivity to the investigational drug
- •History of major surgery or severe trauma within 21 days prior to administration of the investigational drug. Open tissue biopsy within 7 days prior to administration of the investigational drug
- •In men who have not undergone vasectomy, if the partner plans to become pregnant during the study period, or if, even if not planning, is unable to use a medically recognized method of contraception (partner's sterilization, partner's intrauterine device, interstitial contraception, diaphragm, or condom combination)
- •Women and men of childbearing age who are pregnant or breastfeeding, or who do not intend to use appropriate contraception during the study period
- •Cases of central nervous system involvement
- •Cases of prior azacitidine and lenalidomide combination therapy: provided that enrollment is possible if each drug was administered alone or in combination with other drugs
研究者
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