Clinical Trials /

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

NCT04747002

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04747002

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: WT1-AM-05
  • NCT ID: NCT04747002

Conditions

  • Acute Myeloid Leukemia in Remission

Interventions

DrugSynonymsArms
DSP-7888Administration Group

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
Administration GroupActive ComparatorPatients who are injected with DSP-7888.
  • DSP-7888
Non-administration GroupNo InterventionPatients who are only under observation.

    Eligibility Criteria

            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
    Maximum Eligible Age:80 Years
    Minimum Eligible Age:20 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Relapse-free survival
    Time Frame:2 year
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Hematological relapse-free survival
    Time Frame:2 year
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:2 year
    Safety Issue:
    Description:
    Measure:Adverse event
    Time Frame:2 year
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Osaka University

    Last Updated

    March 3, 2021