Combined treatment with conventional chemotherapy and green tea capsules for elderly acute myeloid leukemia patients
- Conditions
- elderly and fragile acute myeloid leukemia patientsC04.557.337.539.275
- Registration Number
- RBR-2tstxd
- Lead Sponsor
- Hemocentro - Universidade Estadual de Campinas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR).<br>SC Ara-C ORR is about 25% and our objective will be achieve at leat 35% ORR.<br>Response criteria for AML patients<br>Overall response rate: percentage of AML patients with complete response (CR), complete response without blood improvement (iCR) or partial response (PR), as defined below:<br>Complete response (CR): <5% bone marrow blasts,without peripheral blasts and granulocytes > 1000 and platelet count > 100,000;<br>iCR: as CR, without granulocyte or platelet improvement;<br>Partial response (PR): at least 50% reduction in bone marrow blast percentage, compared to before therapy. If initial values between 50 and 100%, the value should be reduced at least for 5-25%. If initially were between 20-49%, bone marrow should be reduced at least 50% and the absolute value > 5%<br>
- Secondary Outcome Measures
Name Time Method Overall survival: time frame between study entry and death or lost of follow-up of participants;Improvement of immune cell status: serial quantification of Treg cell, NK cells, monocyte subpopulations