Investigator-initiated Clinical Trial (Phase II) of Cance... | NCT04747002

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

NCT04747002

Sponsor

Osaka University

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Acute Myeloid Leukemia in Remission

Interventions

DSP-7888

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2020Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 5, 2021

First Posted Date

Feb 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2021

Last Update Posted Date

Mar 3, 2021Actual

Name	Class
Japan Agency for Medical Research and Development	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Administration Group	Active Comparator	Patients who are injected with DSP-7888.	Drug: DSP-7888
Non-administration Group	No Intervention	Patients who are only under observation.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSP-7888	Drug	Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides	Administration Group

Measure	Description	Time Frame
Relapse-free survival		2 year

Measure	Description	Time Frame
Hematological relapse-free survival		2 year
Overall survival		2 year
Adverse event

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided