Investigator-initiated clinical trial (Phase II) of cancer vaccine "DSP-7888" for acute myeloid leukemia patients.

JRCT ID: jRCT2051200023

Registered date:03/06/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia
• Date of first enrollment: 12/06/2020
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Intradermal administration of DSP-7888 12 times every 2 weeks, thereafter 18 times every 4 weeks.

Outcome(s)

• Primary Outcome: Relapse-free survival

Secondary Outcome

Hematological relapse-free survival
Overall survival
Adverse ivent

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) acute myeloid leukemia difined by WHO 2016 classification
2) favorable or intermediate risk based on ELN 2017 risk classification
3) 1st hematological after chemotherapy
4) HLA-A*02:01, 02:06, 24:02
5) 20-80 years old
6) ECOG performance Status 0-2
7) whithin 35 days after WBC and Neutrophil recovers over 1500 and 500, respectively
8) safficient organ function as below within 7 days
(1) Neutrophil : >= 1000
(2) Cr : >= 3.0mg/dl
(3) AST, ALT : 5 x the ULN for the reference lab
(4) 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 HSCT
(2) lack of appropriate donor
(3) patients who don't select HSCT at the 1st hCR timing

Exclude criteria

1) multiple primary cancer
2) autoimmune disease
3) usage of investigational or unapproved drug within 28 days
4) severe organ failure
5) HIV antibody / HBs antigen / HCV antibody positive
6) pregnant woman
7) lactating woman
8) under treatment against active infection
9) difficult to enroll becuase of mental problem
10) other reasons which investigator judge appropriate for enrollment

Related Information

• Primary Sponsor: Nakata Jun
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Department of Cancer Immunotherapy, Osaka University