NCT00106431已完成2 期
A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- The Percent of Patients (Pts) With Objective Disease Response
研究概览
简要总结
GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
详细描述
Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria [OPDREC]) that included cutaneous manifestations of disease, lymph node involvement, and circulating malignant T-cells (Sézary cells). Skin involvement was measured using a weighted body surface area skin assessment tool (WBSA/SWAT) or an erythroderma score, depending upon the pt's disease. Disease response was assessed by the Investigators and an Independent Response Review Committee (IRRC) with the IRRC assessment considered supportive of the Investigator's evaluations using the following criteria:
Complete Response (CR):
- Complete resolution of skin patches, skin plaques, and skin tumors, or erythroderma
- No evidence of abnormal lymph nodes
- Absence of circulating Sézary cells.
- No evidence of new tumors (cutaneous or non-cutaneous)
- Findings confirmed by skin biopsy
Clinical complete response (CCR):
- Same as CR but without skin biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had to fulfill all of the following criteria to be eligible for study participation:
- •Males or non-pregnant females aged 18 or over.
- •Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome.
- •Patients with CTCL stages II-A, II-B, III, and IV-A only.
- •Patients with CTCL stage IB who had relapsed following previous therapy and where, in the investigator's opinion, the potential benefit of treatment with romidepsin outweighed the possible risks.
- •Patients who had failed standardized skin-directed therapy and had had at least one course of systemic therapy, such as interferon, Ontak®, chemotherapy or Targretin®, etc., which they were deemed to have failed.
- •Anticipated life expectancy greater than six months.
- •Written informed consent to participate in the study.
排除标准
- •Patients were ineligible for entry if any of the following criteria were met:
- •ECOG Performance Status >
- •Patients who had not received at least 1 course of prior systemic therapy for CTCL.
- •Visceral involvement i.e. Stage 4B disease (lymphadenopathy was allowed).
- •Patients with known cardiac abnormalities such as:
- •Congenital long QT syndrome
- •QTc (Corrected QT interval on ECG) interval >480 milliseconds
- •Any cardiac arrhythmia requiring anti-arrhythmic medication.
- •Patients who had had a myocardial infarction within 12 months of study entry.
- •Patients who had a history of coronary artery disease (CAD) e.g. angina Canadian class II to IV. In any patient in whom there was doubt, the patient should have had a stress imaging study and exercise electrocardiogram (ECG) and, if abnormal, angiography to define whether or not CAD was present.
- •Patients with an ECG recorded at screening showing evidence of cardiac ischaemia (ST depression of >=2 mm). If in any doubt, the patient should have had a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
- •Patients with congestive heart failure that met New York Heart Association class II to IV definitions and/or ejection fraction <40% by multiple gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
- •Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, unless currently addressed with an automatic implantable cardioverter defibrillator (AICD).
- •Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above).
- •Patients with uncontrolled hypertension, i.e. >=160/95 mmHg.
- •Concomitant use of any anti-cancer therapy.
- •Concomitant use of warfarin (due to a drug interaction).
- •Concomitant use of any investigational agent.
- •Use of any investigational agent within 4 weeks of study entry.
- •Concomitant use of drugs which may cause a prolongation of the QTc interval.
- •Patients with a potassium level of <3.5 mmol/L and a magnesium level of <0.8 mmol/L.
- •Clinically significant active infection.
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Inadequate bone marrow or other organ function, as evidenced by:
- •unsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin were permitted);
- •absolute neutrophil count (ANC) <=1.5 x 10^9/L;
- •platelet count <100 x 10^9/L;
- •total bilirubin >1.25 x upper limit of normal (ULN) for institution,
- •aspartate transaminase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/ glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2.0 x ULN for age and sex;
- •Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that had been treated curatively).
- •Any significant medical or psychiatric condition that might have prevented the patient from complying with all study procedures.
- •Patients who were pregnant or breast-feeding. All women of child bearing potential were to use an effective method of contraception (either an intrauterine device or a double barrier method using condoms or a diaphragm plus spermicide) during the study and for at least one month after receiving the last dose of romidepsin. Male patients were to use a barrier method of contraception (condoms) during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl estradiol) were to be avoided due to a potential drug interaction.
- •Use of topical steroids in the previous 2 weeks or systemic steroids in the previous 4 weeks.
- •Having previously given consent to participate in this study.
- •Concomitant use of CYP3A4 inhibitors.
结局指标
主要结局
The Percent of Patients (Pts) With Objective Disease Response
时间窗: 6 months
The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response \[CR\], clinical complete response \[CCR\], or partial response \[PR\]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).
次要结局
- Duration of Objective Disease Response(Up to 10 months; median duration of follow up was 5.1 months)
- Time to Objective Disease Response(Up to 10 months)
- Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.(Up to 10 months)
- Duration of Objective Disease Control (ODC)(Up to 10 months; median duration of follow up was 6.0 months)
- Percent of Pts With Objective Disease Control(Up to 10 months)
- Time to Disease Progression(Up to 10 months; median duration of follow up was 6.1 months)
研究者
研究点 (17)
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