JPRN-jRCT2051200023
Recruiting
Phase 2
Investigator-initiated clinical trial (Phase II) of cancer vaccine DSP-7888 for acute myeloid leukemia patients. - WT1-AM-05
akata Jun0 sites100 target enrollmentJune 3, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute myeloid leukemia
- Sponsor
- akata Jun
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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