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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia in Remission
• Intervention / Treatment: Drug: DSP-7888

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Nakata, M.D., Ph.D.; Phone Number: +81668793676; Email: mogura@sahs.med.osaka-u.ac.jp

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Recruiting
      • Osaka University
      • Contact: Jun Nakata; Phone Number: +81668793676; Email: mogura@sahs.med.osaka-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Administration Group; Patients who are injected with DSP-7888.	Drug: DSP-7888; Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
NO_INTERVENTION: Non-administration Group; Patients who are only under observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse-free survival	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Japan Agency for Medical Research and Development

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2020
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (ACTUAL): February 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: WT1-AM-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No