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

Primary Purpose

Acute Myeloid Leukemia in Remission

Status

Recruiting

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

DSP-7888

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia in Remission

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
1st hematological after chemotherapy
Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
20-80 years old
Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
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.

illegible for hematopoietic stem cell transplantation (HSCT)
lack of appropriate donor
patients who don't select HSCT at the 1st hematological complete remission (hCR) timing

Exclusion Criteria:

multiple primary cancer
autoimmune disease
usage of investigational or unapproved drug within 28 days
severe organ failure
Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
pregnant woman
lactating woman
under treatment against active infection
difficult to enroll because of mental problem
other reasons which investigator judge appropriate for enrollment

Sites / Locations

Osaka UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Administration Group

Non-administration Group

Arm Description

Patients who are injected with DSP-7888.

Patients who are only under observation.

Outcomes

Primary Outcome Measures

Relapse-free survival

Secondary Outcome Measures

Hematological relapse-free survival

Overall survival

Adverse event

Full Information

NCT ID

NCT04747002

First Posted

February 5, 2021

Last Updated

February 28, 2021

Sponsor

Osaka University

Collaborators

Japan Agency for Medical Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04747002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 12, 2020 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Osaka University

Collaborators

Japan Agency for Medical Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia in Remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Administration Group

Arm Type

Active Comparator

Arm Description

Patients who are injected with DSP-7888.

Arm Title

Non-administration Group

Arm Type

No Intervention

Arm Description

Patients who are only under observation.

Intervention Type

Drug

Intervention Name(s)

DSP-7888

Intervention Description

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

Primary Outcome Measure Information:

Title

Relapse-free survival

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Hematological relapse-free survival

Time Frame

2 year

Title

Overall survival

Time Frame

2 year

Title

Adverse event

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification 1st hematological after chemotherapy Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02 20-80 years old Eastern Cooperative Oncology Group (ECOG) performance Status 0-2 within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively 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. illegible for hematopoietic stem cell transplantation (HSCT) lack of appropriate donor patients who don't select HSCT at the 1st hematological complete remission (hCR) timing Exclusion Criteria: multiple primary cancer autoimmune disease usage of investigational or unapproved drug within 28 days severe organ failure Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive pregnant woman lactating woman under treatment against active infection difficult to enroll because of mental problem other reasons which investigator judge appropriate for enrollment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Nakata, M.D., Ph.D.

Phone

+81668793676

mogura@sahs.med.osaka-u.ac.jp

Facility Information:

Facility Name

Osaka University

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Nakata

Phone

+81668793676

mogura@sahs.med.osaka-u.ac.jp

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/AM05.html

Description

Related Info

Learn more about this trial

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

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