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

NCT ID: NCT03083054

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-07-31

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.

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

Group Type: EXPERIMENTAL

Autologous dendritic cells electroporated with WT1 mRNA

Intervention Type: BIOLOGICAL

Production and application of autologous dendritic cells vaccines, 4 doses, biweekly

Interventions

Autologous dendritic cells electroporated with WT1 mRNA

Production and application of autologous dendritic cells vaccines, 4 doses, biweekly

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Bruno Deltreggia Benites

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hematology and Transfusion Medicine Center

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1.140.423

Identifier Type: -

Identifier Source: org_study_id