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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine DSP-7888 for Acute Myeloid Leukemia Patients.

Conditions
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Acute Myeloid Leukemia in Remission

Intervention / Treatment
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* Drug: DSP-7888


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification 1st hematological after chemotherapy Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02 20-80 years old Eastern Cooperative Oncology Group (ECOG) performance Status 0-2 within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively 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. illegible for hematopoietic stem cell transplantation (HSCT) lack of appropriate donor patients who don't select HSCT at the 1st hematological complete remission (hCR) timing Exclusion Criteria: multiple primary cancer autoimmune disease usage of investigational or unapproved drug within 28 days severe organ failure Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive pregnant woman lactating woman under treatment against active infection difficult to enroll because of mental problem other reasons which investigator judge appropriate for enrollment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Administration Group<br>Patients who are injected with DSP-7888. | Drug: DSP-7888<br>* Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides<br>|
| No Intervention: Non-administration Group<br>Patients who are only under observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematological relapse-free survival |  | 2 year | 
| Overall survival |  | 2 year | 
| Adverse event |  | 2 year |