EUCTR2013-001879-20-GB进行中（未招募）1 期
Phase I/II study to determine the maximum tolerated dose and activity of the combination of romidepsin and carfilzomib in relapsed or refractory peripheral T-cell lymphoma - RomiCar
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
- •Age = 16 years of age
- •Life expectancy > 12 weeks
- •ECOG performance status = 2
- •Relapsed or refractory* peripheral T-cell lymphoma including the following histologies: peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, enteropathy associated T-cell lymphoma, extranodal NK/T-cell lymphoma, transformed mycosis fungoides, hepatosplenic T-cell lymphoma
- •Failed at least 1 prior therapy (but no upper limit of prior regimens)
- •Adequate haematopoietic reserve (Hb = 9g/dl, neutrophils = 1.0x109/l and platelets = 100x109/l or = 75x109/l if marrow involvement documented)
- •Adequate liver function (bilirubin = 1.5 x ULN, AST / ALT = 2x ULN)
- •Adequate renal function (creatinine clearance = 20ml/min as assessed by Cockcroft and Gault calculation)
- •Serum potassium = 4.0 mmol/l, calcium = 2.2 mmol/l and magnesium = 0.85 mmol/l prior to trial entry
- •CT measurable disease with at least 1 lesion having short axis > 1.5cm or splenomegaly > 14cm in cranio-caudal length attributable to relapsed lymphoma
- •Ability to give informed consent
- •* For all relapsed patients, relapse must be confirmed by tissue biopsy (or bone marrow trephine if no other tissue available). For refractory patients, a biopsy must have been obtained within the last 6 months and preferably to confirm refractory disease.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Persistent treatment related toxicities of CTCAE v4.0 grade = 2
- •Previous treatment with histone deactylase inhibitor or proteasome inhibitor
- •Need for any other concurrent anti-cancer drug (apart from corticosteroids at a dose equivalent to prednisolone = 7.5mg daily). A steroid prephase may be used but should be stopped by the first day of cycle 1.
- •Concurrent medical illness deemed by the investigator as uncontrolled and/or clinically significant
- •Co-existing active infection requiring parenteral antibiotics
- •Patients unable to swallow oral medication
- •Active infection with HIV, hepatitis B or hepatitis C
- •Radiotherapy* (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 28 days prior to trial entry (or a longer period depending on the defined characteristics of the agents used, please contact the trials office for confirmation). *Limited field radiotherapy to an isolated lesion in bone or soft tissue must be completed 2 weeks prior to trial entry
- •Major surgery within 4 weeks of trial entry
- •Patients with proven CNS involvement
- •QTc interval of = 480ms or patients taking medications that significantly prolong the QT interval (Appendix 7)
- •Clinically significant cardiac disease = NYHA Class III, symptomatic ischaemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within 6 months of trial entry
- •Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry and within 7 days prior to the start of treatment. Postmenopausal females (> 45 years old and without menstruation for > 1 year) and surgically sterilised females are exempt from a pregnancy test)
- •Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy
研究者
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