Multi-center, randomized, open-label and phase II study of bexarotene in patients with adult T-cell leukemia/lymphoma (ATL)

Minophagen Pharmaceutical Co., Ltd.0 个研究点目标入组 38 人开始时间: 2018年11月29日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 已完成
发起方: Minophagen Pharmaceutical Co., Ltd.
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1. Patients who were confirmed as positive for serum anti-HTLV-1 antibody and diagnosed with ATL and who were classified according to the lymphoma research group (LSG) classification as one of the following.
•a) Smoldering type and chronic type not accompanied with unfavorable factor (indolent ATL).
•b) Acute type, lymphoma type, or chronic type accompanied with unfavorable factor (aggressive ATL), or indolent ATL who achieved a response by more than one regimen of chemotherapy (include molecular targeted drugs) with history of acute transformation.
•2. Patients who are 20 years of age or older on the date of obtaining consent to participate in the trial.
•3. Patients with general condition score [Eastern Cooperative Oncology Group (ECOG) Performance Status] 0 to 2 at screening.
•4. Patients whose major organs function are adequate
•a) Patients with adequate renal function (eGFR: 60 mL/min/1.73 m^2 or more if the patient under 65 years old, 45 mL/min/1.73 m^2 or more if the patient 65 years old and over).
•b) Patients with adequate liver function (AST, ALT and total bilirubin are less than 2.5 times the upper limit of the reference value).
•c) Patients with adequate bone marrow function (hemoglobin 8 g/dL or more, neutrophil count 1,000 /uL or more, platelet count 50,000 /uL or more).
•5. Patients with fasting serum triglycerides below 150 mg/dL or patients controlled to 150 mg/dL or less with drugs.
•In the latter case, treatment with a drug for the treatment of dyslipidemia is continued without changing for 2 weeks or more before starting administration of the investigational drug, and the condition is stable.
•6. About fertile female subjects:
•The serum pregnancy test (beta-hCG) performed within 7 days before the start of study drug administration is negative.
•And patients who were contraceptive by the effective methods for the period from 4 weeks before the negative result was obtained until the start of the investigational drug administration.
•7. Patients who can agree to use adequate contraception, hormonal or barrier methods.
•Fertile female subject:
•During the study drug administration and for 1 month after completion of study drug administration.
•Male subjects who have fertile partners:
•During the study drug administration and for 3 months after completion of study drug administration.
•8. Patient who agreed in writing about participation in this trial.

排除标准

•1. ATL patients with central nervous involvement.
•2. Patients complicated with active cancer at screening.
•3. Patients with HTLV-1 associated myelopathy (HAM) or HTLV-1 associated uveitis (HU).
•4. Patient judged by investigator or clinical trial physician to be able to treat by skin-directed therapy.
•5. Patients who are unlikely to survive for more than 24 weeks from the start of study drug administration.
•6. Patients without lesions that can be evaluated by mSWAT at screening.
•7. Patients who have been diagnosed with a skin disorder by a chemotherapy (including molecular targeted drugs) prior to the hospital visit for screening and who are judged by the investigator or the study doctor to have an impact on the evaluation of the drug.
•8. Patients who were administered other investigational drugs within 12 weeks before starting study drug administration.
•9. Pregnant patients, patients who may be pregnant, patients wishing for pregnancy, breastfeeding patients, or patients who can not accept appropriate contraceptive methods.
•10. Patients with or having a history of hypersensitivity to the ingredients of the investigational drug or related preparations (retinoid).
•11. Patients with history of pancreatitis or risk factors for pancreatitis.
•12. Patients with severe complications or severe infections.
•13. Patients with a history of serious allergies or severe drug hypersensitivity.
•14. Patients who do not want to avoid or can not avoid long-time sunlight or UV light.
•15. On other, patients judged not to be appropriate for participation in the trial by investigators.

研究者

发起方

Minophagen Pharmaceutical Co., Ltd.

相似试验

进行中（未招募）

不适用

Multicenter, open-label and randomized phase II study to evaluate safety and efficacy of the tri-functional bispecific antibody catumaxomab(anti-EpCAM x anti-CD3) in patients after curative resection of a confirmed gastric adenocarcinoma compared with surgery aloneAdvanced gastric adenocarcinoma and intended curative gastrectomy (R0 resection).MedDRA version: 8.1Level: HLTClassification code 10017812Term: Gastric neoplasms malignant

EUCTR2005-005945-20-DEFresenius Biotech GmbH70

进行中（未招募）

1 期

Multi-center, open-label, non-randomised phase II study to evaluate the activity and tolerability of GW786034 in patients with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists. - VEG20002

EUCTR2004-004378-10-GBGlaxoSmithKline Research & Development Ltd142

进行中（未招募）

不适用

EUCTR2004-004378-10-BEGlaxoSmithKline Research & Development Ltd148

进行中（未招募）

不适用

EUCTR2004-004378-10-HUGlaxoSmithKline Research & Development Ltd148

进行中（未招募）

1 期

Open-label, multi-center, randomized, two stage adaptive design study of the combination of bevacizumab with standard chemotherapy in minor patients with metastatic rhabdomyosarcoma, non-rhabdomyosarcoma soft-tissue sarcoma or Ewing’s sarcoma/soft-tissue primitive neuroectodermal tumors.

EUCTR2007-005017-19-FRF. Hoffmann-La Roche Ltd154