Acute myeloid leukemia / High-risk myelodysplastic syndromes
Conditions
Interventions
Phase II, double-blind, placebo-controlled interventional study. Patients (n=40) will be randomized with the use of exchange in blocks of varying sizes ??for administration of cytarabine in low doses,
SHANAFELT et al., 2009). Treatment with EGCG may be administered alone, if the patient does not present clinical conditions (such as heart disease or advanced nephropathy) for the use of associated pa
C92.0
Sponsors
Centro de Hematologia e Hemoterapia de Campinas - Hemocentro da Unicamp
Centro de Hematologia e Hemoterapia de Campinas - Hemocentro da Unicamp
Eligibility
Inclusion criteria
Inclusion criteria: Age 60 years and over; Patients under age 60 will be allowed if they are found to be ineligible for high-dose conventional chemotherapy due to comorbidities; Patients with newly diagnosed or relapsed AML (myeloid blasts in peripheral blood or bone marrow above 20%); Patients with newly diagnosed of MDS with excess blasts (>10% blasts on myelogram or bone marrow biopsy); Performance status between 0 and 3 on the WHO-ECOG scale; Last chemotherapy treatment performed at least 60 days ago; Patients using hydroxyurea to control leukocytosis before starting study and can be maintained for up to 60 days; Patients who agree to participate in the study, after full understanding of the informed consent and voluntary signature of the informed consent.
Exclusion criteria
Exclusion criteria: Presence of psychiatric illness or other illness that affects the understanding of the informed consent; History of any previous neoplasm, with the exception of prolonged remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ; Previous immunotherapy or biological therapy; Severe renal failure, characterized by creatinine clearance <30mL/minute; Total bilirubin above or equal to twice the upper limit of normality; AST and/or ALT above or equal to twice the upper limit of normality; Positive serologies for HCV, HBV or HIV; Uncontrolled intercurrent illness, such as active infection requiring antibiotic use, symptomatic congestive heart failure (NYHA class III or IV), or unstable angina; Women of childbearing age who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global response in LMA and SMD with excess blasts (CHESON et al., 2003), verified by myelogram and hemogram, from the verification of the percentage of patients who achieve complete response (CR), complete response with incomplete hematological recovery (RCi) or partial response (RP), as set out below: ? Complete response (CR): absence of blasts in peripheral blood, 1000 and platelets > 100mil; ? Complete response with incomplete hematologic (CRi): as CR but without neutrophil and/or platelet recovery; ? Partial response (PR): at least 50% reduction in the percentage of blasts compared to the start of treatment. If the starting percentage is between 50 and 100%, it should reduce to the range of 5-25%. If at the beginning it is between 20-49%, it should be reduced by more than 50% and to a value > 5%. In the presence of 10 to 20% of blasts in OM (SMD with excess blasts) there should be a reduction of more than 50% in the blast count, but still above 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1 Erythroid hematologic response, verified according to the criteria of the group "International Working Group (IWG) 2006 (CHESON et al., 2006), as follows: ? Increased hemoglobin > 1.5g/dL compared to values ??before the start of the study and/or ? Relevant reduction in the transfusion requirement of RBC units of at least 4 RBC units (RBC) in 8 weeks, compared to the number transfused in the 8 weeks prior to the study. Only RBC transfusions administered with Hb 30,000 for patients with basal platelets above 20,000; ? Increase from 20,000 and from at least 100%. ? Response in neutrophils (pre-treatment values ??500;Secondary outcome 3 Immunological improvement, verified by subpopulations of T lymphocytes, NK cells and monocytes subtypes, based on the finding of a variation of at least 5% in pre- and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactSara T. Saad
Outcome results
None listed