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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083054
Recruitment Status : Active, not recruiting
First Posted : March 17, 2017
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bruno Deltreggia Benites, 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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Acute Myeloid Leukemia Biological: Autologous dendritic cells electroporated with WT1 mRNA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cellular Immunotherapy as a Treatment Option for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 12, 2020
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Patients
High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia
Biological: Autologous dendritic cells electroporated with WT1 mRNA
Production and application of autologous dendritic cells vaccines, 4 doses, biweekly




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083054


Locations
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Brazil
Hematology and Transfusion Medicine Center
Campinas, São Paulo, Brazil, 13083-870
Sponsors and Collaborators
University of Campinas, Brazil
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Responsible Party: Bruno Deltreggia Benites, Principal Investigator, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03083054    
Other Study ID Numbers: 1.140.423
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions