Green tea as immunomodulation and antineoplastic therapy for elderly Acute Myeloid Leukemia unfit for high dose conventional chemotherapy

Hemocentro - Universidade Estadual de Campinas0 个研究点开始时间: 2018年10月18日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Patients with AML according 2016 WHO classification, including de novo and secondary AML; age over 60 years; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; informed consent, personally signed (or legal responsible person) and dated to participate in the study; be able to comply with study procedures and follow-up examinations; last chemotherapy regimen at least 60 days ago. Hydroxiurea use is allowed.

•Psychiatric disorders that would interfere with consent, study participation, or follow-up; chronically impaired renal function (creatinine clearance < 30 ml / min); inadequate liver function (ALT and AST over 2.5 x ULN) if not caused by leukemic infiltration; total bilirubin over 1.5 x ULN if not caused by leukemic infiltration; known HIV and/or hepatitis C infection; diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed; history of organ allograft; patients who have an indication for and can undergo a non-myeloablative transplant procedure; cardiac Disease: Heart failure NYHA class 3 or 4; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).

发起方

Hemocentro - Universidade Estadual de Campinas