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

• Sponsor: Osaka University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04747002
• Collaborator: Japan Agency for Medical Research and Development (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.6
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Jun 12, 2020
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Primary Outcome Measures

1. Relapse-free survival [2 year]

Secondary Outcome Measures

1. Hematological relapse-free survival [2 year]

2. Overall survival [2 year]

3. Adverse event [2 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: 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:

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

Locations

	Site	City	State	Country	Postal Code
1	Osaka University	Suita	Osaka	Japan	565-0871

Sponsors and Collaborators

• Osaka University
• Japan Agency for Medical Research and Development

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Yoichi Yamamoto, Professor, Osaka University
• ClinicalTrials.gov Identifier: NCT04747002
• Other Study ID Numbers: WT1-AM-05
• First Posted: Feb 10, 2021
• Last Update Posted: Mar 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Mar 3, 2021