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

NCT04747002 | Unknown Phase 2

• 1 other identifier: WT1-AM-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia in Remission

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  2 year

Secondary Outcomes (3)

• Hematological relapse-free survival

  2 year

• Overall survival

  2 year

• Adverse event

  2 year

Study Arms (2)

Administration Group

ACTIVE COMPARATOR

Patients who are injected with DSP-7888.

Drug: DSP-7888

Non-administration Group

NO INTERVENTION

Patients who are only under observation.

Interventions

DSP-7888 DRUG

Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides

Administration Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
• favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
• st hematological after chemotherapy
• Human Leukocyte Antigen (HLA)-A\*02:01, 02:06, 24:02
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka University: lead
• Japan Agency for Medical Research and Development: collaborator

Study Sites (1)

Osaka University

Suita, Osaka, 565-0871, Japan

RECRUITING

Related Links

• Related Info

Central Study Contacts

Jun Nakata, M.D., Ph.D.

CONTACT

+81668793676; mogura@sahs.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: June 12, 2020
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)