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

Phase 1

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes
• Interventions: Biological: Autologous dendritic cells electroporated with WT1 mRNA

• Registration Number: NCT03083054
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-03-12
• Study First Posted: 2017-03-17
• Primary Completion: 2020-07-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Autologous dendritic cells electroporated with WT1 mRNA	High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

Primary Outcome Measures

Name	Time	Method
Disease free survival	12 months

Trial Locations

Locations (1)

Hematology and Transfusion Medicine Center; 🇧🇷 Campinas, São Paulo, Brazil