CClinicalTrials.gg
Status unknownNCT04747002Updated Mar 3, 2021

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

A Phase 2 interventional study of DSP-7888 in Acute Myeloid Leukemia in Remission, sponsored by Osaka University. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Osaka University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2020, registered Feb 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Myeloid Leukemia in Remission
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Osaka University is the lead sponsor of 33 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Administration Group

    Patients who are injected with DSP-7888.

    Drug: DSP-7888

  • No intervention
    Non-administration Group

    Patients who are only under observation.

Interventions

  • DrugDSP-7888

    Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides

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What researchers measure

Primary outcomes

  1. Relapse-free survival

    Time frame: 2 year

Secondary outcomes

  1. Hematological relapse-free survival

    Time frame: 2 year

  2. Overall survival

    Time frame: 2 year

  3. Adverse event

    Time frame: 2 year

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Study locations

1 of 1 sites recruiting
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04747002
Lead sponsor
Osaka University
Collaborators
Japan Agency for Medical Research and Development
Responsible party
Yoichi Yamamoto (Professor, Osaka University) — Principal investigator
First posted
Feb 10, 2021
Start date
Jun 12, 2020
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Mar 3, 2021

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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