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.

Full Title of Study: “Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine “DSP-7888″ for Acute Myeloid Leukemia Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2024

Detailed 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.

Interventions

  • Drug: DSP-7888
    • Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides

Arms, Groups and Cohorts

  • Active Comparator: Administration Group
    • Patients who are injected with DSP-7888.
  • No Intervention: Non-administration Group
    • Patients who are only under observation.

Clinical Trial Outcome Measures

Primary Measures

  • Relapse-free survival
    • Time Frame: 2 year

Secondary Measures

  • Hematological relapse-free survival
    • Time Frame: 2 year
  • Overall survival
    • Time Frame: 2 year
  • Adverse event
    • Time Frame: 2 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Osaka University
  • Collaborator
    • Japan Agency for Medical Research and Development
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yoichi Yamamoto, Professor – Osaka University
  • Overall Contact(s)
    • Jun Nakata, M.D., Ph.D., +81668793676, mogura@sahs.med.osaka-u.ac.jp

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