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

NCT03083054 | Unknown Phase 1 DMC

• 1 other identifier: 1.140.423
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  12 months

Study Arms (1)

Patients

EXPERIMENTAL

High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

Biological: Autologous dendritic cells electroporated with WT1 mRNA

Interventions

Autologous dendritic cells electroporated with WT1 mRNA BIOLOGICAL

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

Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Hematology and Transfusion Medicine Center

Campinas, São Paulo, 13083-870, Brazil

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: August 1, 2016
• Primary Completion: July 12, 2020
• Study Completion: July 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)