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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03083054
• Other study ID #: 1.140.423
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 2016
• Est. completion date: July 2021

Study information

• Verified date: October 2020
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: July 2021
• Est. primary completion date: July 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Biological:
• Autologous dendritic cells electroporated with WT1 mRNA
Production and application of autologous dendritic cells vaccines, 4 doses, biweekly

Locations

Country	Name	City	State
Brazil	Hematology and Transfusion Medicine Center	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		12 months