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

University of Campinas, Brazil

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Myelodysplastic Syndromes

Acute Myeloid Leukemia

Treatments

Biological: Autologous dendritic cells electroporated with WT1 mRNA

Study type

Interventional

Funder types

Other

Identifiers

NCT03083054

1.140.423

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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