RAdiotherapy in combination with Maintenance Systemic pegylated Interferon therapy for Mycosis FungoideS (RAMSIS) - RAMSIS

niversitätsklinikum Münster0 个研究点目标入组 56 人开始时间: 2023年5月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histologically confirmed diagnosis of MF stage IB-IV
•Insufficient response to at least one prior systemic or topical therapy
•Age = 18 years
•Wash-out period of 4 weeks before systemic therapy and 2 weeks before topical therapy to minimize latent clinical benefit or residual toxicity related to prior treatment
•Written informed consent for study participation
•Life expectancy > 6 months
•Eastern Cooperative Oncology Group score = 2
•Adequate bone marrow function: white blood count = 3000/uL; platelet count = 100,000/mm3; hemoglobin =10 g/dL
•Estimated creatinine clearance > 40 mL/min.
•Aspartate aminotransferase or alanine aminotransferase value less than 2 times the upper limit of normal
•Serum total bilirubin < 1.5 times the upper limit of normal

•Prior TSEB course. Localized radiotherapy must have ended at least 4 weeks prior to study enrollment.
•Serious illness or medical history that would impair the patient’s ability to undergo radioimmunotherapy.
•Prior or active skin malignancy (except for completely excised, non-invasive basal cell or squamous cell carcinoma diagnosed > 2 years prior to enrollment)
•Uncontrolled bacterial or fungal infection at time of enrollment
•Active or prior autoimmune disease requiring systemic treatment
•Active or prior non-infectious pneumonitis requiring steroids or pulmonary fibrosis
•Pregnancy or lactation; Women of childbearing age with reproductive potential should use adequate birth control measures during the study treatment period and for at least 5 months after treatment.

发起方

niversitätsklinikum Münster