elderly and fragile acute myeloid leukemia patients
Conditions
Interventions
20 elderly patients with acute myeloid leukemia patients unfit and not eligible for conventional chemotherapy will be recruted and, if fullfill eligibility criteria and agree to participate, they will
Drug
C04.557.337.539.275
D03.383.742.680.245.453
Sponsors
Hemocentro - Universidade Estadual de Campinas
Hemocentro - Universidade Estadual de Campinas
Eligibility
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR). SC Ara-C ORR is about 25% and our objective will be achieve at leat 35% ORR. Response criteria for AML patients Overall response rate: percentage of AML patients with complete response (CR), complete response without blood improvement (iCR) or partial response (PR), as defined below: Complete response (CR): 1000 and platelet count > 100,000; iCR: as CR, without granulocyte or platelet improvement; 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% | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactFernando Pericole
Hemocentro - Universidade Estadual de Campinas
Outcome results
None listed