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

Phase 2

• Conditions: Acute Myeloid Leukemia in Remission
• Interventions: Drug: DSP-7888

• Registration Number: NCT04747002
• Lead Sponsor: Osaka University

Brief Summary

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.

Study Timeline

• Study Start: 2020-06-12
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-03
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration Group	DSP-7888	Patients who are injected with DSP-7888.

Primary Outcome Measures

Name	Time	Method
Relapse-free survival	2 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 year
Adverse event	2 year
Hematological relapse-free survival	2 year

Trial Locations

Locations (1)

Osaka University; 🇯🇵 Suita, Osaka, Japan