临床试验/NCT02203578

NCT02203578终止不适用

A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease

Rutgers, The State University of New Jersey1 个研究点分布在 1 个国家目标入组 1 人开始时间: 2014年11月最近更新: 2017年3月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: Rutgers, The State University of New Jersey
入组人数: 1
试验地点: 1
主要终点: Incidence of aGVHD

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

详细描述

PRIMARY OBJECTIVES:

I. To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Supportive Care
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 with steroid (or immunosuppressive therapy [IST]) refractory acute GVHD (aGVHD) or chronic GVHD (cGVHD)
•Absolute neutrophil count >= 750/mm^3
•Platelet count >= 50,000/mm^3
•Corrected QT interval (QTc) =< 480 msec
•Bilirubin =< 1.5 x upper limit of normal (ULN)
•Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN
•Serum potassium >= 3.8 mmol/L
•Serum magnesium >= 1.8 mg/dL
•Serum creatinine =< 2.0 mg/dl
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
•Patients may undergo electrolyte repletion therapy to meet eligibility requirements
•Patients must be scheduled for tapering doses of (or no longer treated with):
•Cyclosporine;
•Tacrolimus;
•Sirolimus;
•Steroids (patients may be on physiologic doses of steroids)
•Patients receiving extracorporeal photopheresis must discontinue extracorporeal photopheresis or placed on a tapering schedule;
•Any prior therapy for GVHD must be completed and discontinued with the exception of the above;
•Patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxis
•There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy
•The patient must be aware of the high risk and experimental nature of the treatment and provide informed consent
•Negative serum pregnancy test at the time of enrollment for females of childbearing potential
•For males and females of child-producing potential, use of effective contraceptive methods during the study and for at least 6 months after the last dose of romidepsin

排除标准

•Active/uncontrolled infection
•Evidence of relapsed disease
•Life expectancy < 12 weeks
•Pregnant or breast feeding females
•Prior therapy with romidepsin
•Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible
•Any known cardiac abnormalities such as:
•Congenital long QT syndrome
•QTc interval >= 480 milliseconds;
•Myocardial infarction within 6 months of course 1, day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
•Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
•Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
•An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
•Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by multi gated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI);
•A known 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);
•Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other cause;
•Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
•Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
•Patients taking drugs leading to significant QT prolongation must have an ECG prior to each treatment
•Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
•Concomitant use of medications known to induce a disulfiram-like reaction to alcohol

研究组 & 干预措施

Supportive care (romidepsin)

Experimental

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

干预措施: romidepsin (Drug)

Supportive care (romidepsin)

Experimental

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

干预措施: laboratory biomarker analysis (Other)

结局指标

主要结局

Incidence of aGVHD

时间窗: At 28 days after initiation of romidepsin

Incidence of cGVHD

时间窗: At 12 months after initiation of romidepsin

次要结局

T Cell Kinetics - Reconstitution(Up to 12 months after initiation of romidepsin)
Total Duration of Immunosuppressive Therapy(Up to 12 months after initiation of romidepsin)
Rate of Documented Infection(Up to 12 months after initiation of romidepsin)

研究者

发起方

Rutgers, The State University of New Jersey

申办方类型

Other

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

终止

2 期

Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host DiseaseChronic Graft Versus Host Disease

NCT02337517National Cancer Institute (NCI)6

已完成

2 期

Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Promyelocytic Leukemia (M3)Recurrent Adult Acute Myeloid Leukemia

NCT00062075National Cancer Institute (NCI)47

已完成

2 期

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell LymphomaPeripheral T-cell Lymphoma

NCT00426764Celgene131

已完成

2 期

Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)Chronic Graft-versus-host Disease

NCT01161628Northside Hospital, Inc.25

终止

2 期

NCT01044745University of Nebraska20