Investigator-initiated clinical trial (Phase II) of cancer vaccine DSP-7888 for acute myeloid leukemia patients.
- Conditions
- Acute myeloid leukemiaAMLD015470
- Registration Number
- JPRN-jRCT2051200023
- Lead Sponsor
- akata Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Hematological relapse-free survival<br>Overall survival<br>Adverse ivent