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NCT04747002 Clinical Trial

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

Acute Myeloid Leukemia in Remission Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04747002
Other study ID # WT1-AM-05
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 12, 2020
Est. completion date April 2024

Study information
Verified date February 2021
Source Osaka University
Contact Jun Nakata, M.D., Ph.D.
Phone +81668793676
Email mogura@sahs.med.osaka-u.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DSP-7888
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides

Locations
Country Name City State
Japan Osaka University Suita Osaka

Sponsors (2)
Lead Sponsor Collaborator
Osaka University Japan Agency for Medical Research and Development

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse-free survival 2 year
Secondary Hematological relapse-free survival 2 year
Secondary Overall survival 2 year
Secondary Adverse event 2 year
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