Status:
UNKNOWN
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.
Lead Sponsor:
Osaka University
Collaborating Sponsors:
Japan Agency for Medical Research and Development
Conditions:
Acute Myeloid Leukemia in Remission
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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 peptid...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04747002
Start Date
June 12 2020
End Date
April 1 2024
Last Update
March 3 2021
Active Locations (1)
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1
Osaka University
Suita, Osaka, Japan, 565-0871