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Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.

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ClinicalTrials.gov Identifier: NCT04747002
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
Yoichi Yamamoto, Osaka University

Study Description
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Brief Summary:
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia in Remission Drug: DSP-7888 Phase 2

Detailed Description:
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Administration Group
Patients who are injected with DSP-7888.
 Drug: DSP-7888
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
No Intervention: Non-administration Group
Patients who are only under observation.


Outcome Measures
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Primary Outcome Measures :
  1. Relapse-free survival [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Hematological relapse-free survival [ Time Frame: 2 year ]
  2. Overall survival [ Time Frame: 2 year ]
  3. Adverse event [ Time Frame: 2 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
  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:

  1. multiple primary cancer
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747002


Contacts
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Contact: Jun Nakata, M.D., Ph.D. +81668793676 mogura@sahs.med.osaka-u.ac.jp

Locations
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Japan
Osaka University Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Jun Nakata    +81668793676    mogura@sahs.med.osaka-u.ac.jp   
Sponsors and Collaborators
Osaka University
Japan Agency for Medical Research and Development
More Information
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Additional Information:

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Responsible Party: Yoichi Yamamoto, Professor, Osaka University
ClinicalTrials.gov Identifier: NCT04747002    
Other Study ID Numbers: WT1-AM-05
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms