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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03083054
• Date of registration: 12/03/2017
• Prospective Registration: No
• Primary sponsor: University of Campinas, Brazil
• Public title: Cellular Immunotherapy for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
• Scientific title: Cellular Immunotherapy as a Treatment Option for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
• Date of first enrolment: August 2016
• Target sample size: 5
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03083054
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Brazil

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Intervention(s)

Biological: Autologous dendritic cells electroporated with WT1 mRNA

Primary Outcome(s)

Disease free survival [Time Frame: 12 months]

Secondary ID(s)

1.140.423

Source(s) of Monetary Support

Please refer to primary and secondary sponsors