Photopheresis in Early-stage Mycosis Fungoides

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
  Extracorporeal Photopheresis (ECP)
• Устройство THERAKOS® CELLEX photopheresis system
  THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system

Первичные конечные точки

• Overall Response Rate [Срок оценки: 1 Year]

Вторичные конечные точки (7)

• Time to Response of Photopheresis Therapy [Срок оценки: 1 Year]
• Duration of Response [Срок оценки: 1 Year]
• Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score [Срок оценки: Baseline and 1 Year]
• Change in Skindex-29 Score [Срок оценки: Baseline and 1 Year]
• Change in Short Form Survey (SF-36v2) Score [Срок оценки: Baseline and 1 Year]
• Change in Size of Lymph Nodes [Срок оценки: Baseline and 1 Year]
• Change in Sézary Cell Counts at 6 and at 12 months [Срок оценки: Baseline, 6 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT05680558 · AAAS9960

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗