Acute myeloid leukemia AML
Conditions
Interventions
Intradermal administration of DSP-7888 12 times every 2 weeks, thereafter 18 times every 4 weeks.
D019496
Sponsors
Nakata Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological relapse-free survival Overall survival Adverse ivent | — |
Contacts
Public ContactJun Nakata
Osaka University
Outcome results
None listed