Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.

Overview

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.

Description

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.

Eligibility

Inclusion Criteria:

1. acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
2. favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
3. 1st hematological after chemotherapy
4. Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
5. 20-80 years old
6. Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
7. within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
8. sufficient organ function as below within 7 days

        (1) Neutrophil : >= 1000 (2) Cr : >= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine
        transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4)
        Percutaneous oxygen saturation (SpO2): >= 95% 9) patients who agree contraception until 6
        months after the last injection 10) non-candidate for hematopoietic stem cell
        transplantation.
          1. illegible for hematopoietic stem cell transplantation (HSCT)
          2. lack of appropriate donor
          3. patients who don't select HSCT at the 1st hematological complete remission (hCR)
             timing
        Exclusion Criteria:
          1. multiple primary cancer
          2. autoimmune disease
          3. usage of investigational or unapproved drug within 28 days
          4. severe organ failure
          5. Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen /
             Hepatitis C Virus (HCV) antibody positive
          6. pregnant woman
          7. lactating woman
          8. under treatment against active infection
          9. difficult to enroll because of mental problem
         10. other reasons which investigator judge appropriate for enrollment