Cellular Immunotherapy for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

Study Overview
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Brief Summary
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The main objective of this work is to conduct a clinical study for the development and application of a vaccine with autologous dendritic cells submitted to electroporation with Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the disease or its relapse and increase overall and event-free survival.

Official Title
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Cellular Immunotherapy as a Treatment Option for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

Conditions
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Myelodysplastic Syndromes, Acute Myeloid Leukemia

Intervention / Treatment
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* Biological: Autologous dendritic cells electroporated with WT1 mRNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals between the ages of 18 and 70 High-risk myelodysplasia (AREB 1 or AREB 2 subtypes) and Acute Myeloid Leukemia Minimum interval of 30 days between the last cycle of chemotherapy (when it occurs) and start of immunotherapy Performance status between 0 and 3 on the WHO (World Health Organization)-ECOG (Eastern Cooperative Oncology Group) scale Calculated creatinine clearance> 30 ml / min using the Cockcroft-Gault formula Total bilirubin less than or equal to twice the lower limit of the normal range in the institution and aspartate aminotransferase (AST) less than or equal to twice the upper limit of normal Absence of blasts in peripheral blood Leukocyte count greater than 3000 cells / mm3, hemoglobin greater than 9.0 g / dl and platelets greater than 70,000 platelets / mm3, if possible. (If the patient does not meet these criteria for apheresis, the possibility of transfusion of blood components after leukapheresis will be proposed and the patient should sign a specific term of science on the possibility of transfusion) Normal cardiac evaluation Negative serologies for hepatitis B and C viruses and HIV Written informed consent form signed before entering the study Exclusion Criteria: Does not meet any of the requirements of the inclusion criteria Low risk myelodysplasia by IPSS (International Prognostic Scoring System) or WPSS (WHO adapted Prognostic Scoring System) scores Individuals with a history of any previous neoplasia, except those with prolonged clinical remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ Pregnant or lactating women Previous immunotherapy or biological therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia | Biological: Autologous dendritic cells electroporated with WT1 mRNA<br>* Production and application of autologous dendritic cells vaccines, 4 doses, biweekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 12 months |