Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.
NCT ID: NCT04747002
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2020-06-12
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Administration Group
Patients who are injected with DSP-7888.
DSP-7888
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
Non-administration Group
Patients who are only under observation.
No interventions assigned to this group
Interventions
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DSP-7888
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
Eligibility Criteria
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Inclusion Criteria
2. favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
3. 1st hematological after chemotherapy
4. Human Leukocyte Antigen (HLA)-A\*02:01, 02:06, 24:02
5. 20-80 years old
6. Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
7. within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
8. 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.
1. illegible for hematopoietic stem cell transplantation (HSCT)
2. lack of appropriate donor
3. patients who don't select HSCT at the 1st hematological complete remission (hCR) timing
Exclusion Criteria
2. autoimmune disease
3. usage of investigational or unapproved drug within 28 days
4. severe organ failure
5. Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
6. pregnant woman
7. lactating woman
8. under treatment against active infection
9. difficult to enroll because of mental problem
10. other reasons which investigator judge appropriate for enrollment
20 Years
80 Years
ALL
No
Sponsors
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Japan Agency for Medical Research and Development
OTHER_GOV
Osaka University
OTHER
Responsible Party
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Yoichi Yamamoto
Professor
Locations
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Osaka University
Suita, Osaka, Japan
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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WT1-AM-05
Identifier Type: -
Identifier Source: org_study_id
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