Single-center, open-label, single-arm study to investigate efficacy and safety of Hydroxychloroquine in Adult T-Cell Leukemia-Lymphoma (ATLL) patients with skin lesions

Amano Masahiro0 个研究点目标入组 5 人开始时间: 2023年1月26日最近更新: 2024年1月22日

研究概览

暂无简介。

•1 Age greater than or equal to18years
•2 Patients with HTLV1 sero positive, pathologically and hematologically verified Adult Tcell leukemia lymphoma at diagnosis of peripheral lymphoid tumor with proven Tcell origin based on surface traits
•3 Patients with any of the following types of ATLL
•Patients with smoldering or chronic ATLL without poor prognostic factors without a history of acute transformation
•4 Patients considered refractory to local treatment e.g. topical steroid therapy, ultraviolet light therapy, and radiation therapy.
•5 Eastern Cooperative Oncology Group performance status of 0 to 2
•6 Patients with preserved major organ function who meet the following criteria at screening;
•Adequate renal function eGFR Upper 50mL per min per 1.73m2
•Adequate liver function AST, ALT, and total bilirubin 2.5 x facility normal range
•Adequate bone marrow function hemoglobin 8 g per dL or more, neutrophil count 1,000 per uL or more, platelet count 50000 per uL or more
•7 For Fertile women
•Confirmed negative with pregnancy test performed within 14 days prior to the start of study drug administration, and have used an effective method of contraception prior to the start of study drug administration.
•8 For Fertile women
•Patients who can agree to use effective method of contraception from screening to 3month after completion of study drug administration.
•9 Patients who have given a written informed consent

•1)Presence of CNS involvement with ATLL
•2)Presence of complicated active cancer at screening
•3)HAM or HAU patient
•4)Life expectancy of less than 24 weeks from the start of study drug administration
•5)No presence of mSWAT-evaluable lesion at screening
•6)Patients who developed a skin disorder due to chemotherapy and have judged inadequate to evaluate the study drug
•7) Patients who are using prohibited concomitant medications and who do not agree to the prohibition of concomitant use during the study period or for a specified period as indicated by the PI or SI.
•8)Pregnant or possibly pregnant
•9)History or suspected history of hypersensitivity to HCQ
•10)Concurrent diagnosis of retinopathy or maculopathy, or history of these diseases
•11)Concurrent diagnosis of serious complications or severe infections
•12)Patients judged ineligible for this study

发起方

Amano Masahiro