THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.
详细描述
The THERAKOS® CELLEX Photopheresis System is currently FDA approved and indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients not responsive to other forms of treatment. The original studies in CTCL were performed in patients having extensive patch/plaque or erythrodermic stage disease. Therefore, photopheresis is used primarily to treat stage III or IV CTCL. However, studies have shown that 50% of patients with early disease may have clonal T-cells in their peripheral blood if polymerase chain reaction is used to amplify the T-cell receptor gamma gene fragments. Thus, patients who are staged as T1 or T2 who also have slight abnormalities in blood involvement, such as atypical cells seen on blood smear or abnormal flow cytometry may benefit from photopheresis therapy. This study aims to investigate the efficacy of photopheresis therapy in patients with Stage !A, 1B, or IIA CTCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Who are male or female, over the age of 18 and <40 kg body weight with adequate veins to provide intravenous access.
- •Who are willing to adhere to the protocol and sign an Informed Patient Consent Document
- •Must not be on any other investigational device/drug treatment.
- •Who have the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotropic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.
- •With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
- •With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
- •Must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA or UVB Therapy - 4 weeks, topical nitrogen mustard or other topical chemotherapy - 4 weeks, bexarotene capsules or other systemic biologic agent - 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone , oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency
- •Who are refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, topical nitrogen mustard, Bexarotene, PUVA therapy, electron beam radiation, biological response modifiers or oral methotrexate.
- •Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.
排除标准
- •Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
- •Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
- •With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
- •With lipemic plasma >500 ng/dL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or Hepatitis B Surface Antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.
- •On oral prednisone therapy or high potency topical steroids.
- •Who are pregnant or nursing a child.
研究组 & 干预措施
UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
TREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months.
干预措施: THERAKOS® CELLEX photopheresis system (Device)
UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
TREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months.
干预措施: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 1 Year
Overall response rate at 1 year measured by the modified skin-weighted assessment tool (mSWAT) in accordance with Olsen et al criteria for response in clinical trial. Measurable lesions are defined as those that can be accurately measured in at least one dimension.
次要结局
- Duration of Response(1 Year)
- Change in Short Form Survey (SF-36v2) Score(Baseline and 1 Year)
- Time to Response of Photopheresis Therapy(1 Year)
- Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score(Baseline and 1 Year)
- Change in Skindex-29 Score(Baseline and 1 Year)
- Change in Size of Lymph Nodes(Baseline and 1 Year)
- Change in Sézary Cell Counts at 6 and at 12 months(Baseline, 6 months and 12 months)
研究者
Larisa Geskin, MD
Director, Cutaneous Oncology
Columbia University