Clinical trial · Interventional
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.
NCT04747002CI-TRIAL-00050433unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia in Remission | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSP-7888 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Administration Group
- description
- Patients who are injected with DSP-7888.
- interventionNames
- Drug: DSP-7888
- type
- NO_INTERVENTION
- label
- Non-administration Group
- description
- Patients who are only under observation.
Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- 2 year
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.