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

Acute Myeloid Leukemia in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747002
• Other study ID #: WT1-AM-05
• Status: Recruiting
• Phase: Phase 2
• Start date: June 12, 2020
• Est. completion date: April 2024

Study information

• Verified date: February 2021
• Source: Osaka University
• Contact: Jun Nakata, M.D., Ph.D.
• Phone: +81668793676
• Email: mogura[@]sahs.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia in Remission
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• DSP-7888
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides

Locations

Country	Name	City	State
Japan	Osaka University	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Japan Agency for Medical Research and Development

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival		2 year
Secondary	Hematological relapse-free survival		2 year
Secondary	Overall survival		2 year
Secondary	Adverse event		2 year

External Links

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