UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045499
Receipt number R000051490
Scientific Title Follow up study of Phase II clinical trial of OCV-501
Date of disclosure of the study information 2021/09/16
Last modified on 2022/08/05 16:14:36

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Basic information

Public title

Follow up study of Phase II clinical trial of OCV-501

Acronym

NMC-OCV501-AML

Scientific Title

Follow up study of Phase II clinical trial of OCV-501

Scientific Title:Acronym

NMC-OCV501-AML

Region

Japan


Condition

Condition

acute myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate a long-term follow-up of patients 60 years or older with acute myeloid leukemia (AML) who participated in the phase 2 randomized trial to evaluate the efficacy and safety of OCV-501 monotherapy or placebo (#NCT01961882).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

5-year disease free survival; OCV-501 group vs. placebo group

Key secondary outcomes

5-year overall survival; OCV-501 group vs. placebo group
Specific immunological responses to WT-1 and prognosis
Level of WT1 mRNA and prognosis


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Registered cases in OCV-501 Phase II study

Key exclusion criteria

1) Cases showing a manifestation of non-participation in this study
2) Cases who the principal investigator deems inappropriate as a research subject

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tomoki
Middle name
Last name Naoe

Organization

National Hospital Organization Nagoya Medical Center

Division name

Honorary Director

Zip code

460-0001

Address

4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan

TEL

052-951-1111

Email

naoe.tomoki.wx@mail.hosp.go.jp


Public contact

Name of contact person

1st name Tomoki
Middle name
Last name Naoe

Organization

National Hospital Organization Nagoya Medical Center

Division name

Honorary Director

Zip code

460-0001

Address

4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan

TEL

052-951-1111

Homepage URL


Email

naoe.tomoki.wx@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Nagoya Medical Center IRB

Institute

Department

Personal name



Funding Source

Organization

International Institute of Cancer Immunology, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Nagoya Medical Center IRB

Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001 JAPAN, Aichi

Tel

052-951-1111

Email

311-rec@mail.hosp.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 16 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

133

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 09 Month 07 Day

Date of IRB

2021 Year 09 Month 15 Day

Anticipated trial start date

2021 Year 09 Month 16 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

5-year disease free survival; OCV-501 group vs. placebo group
5-year overall survival; OCV-501 group vs. placebo group
Specific immunological responses to WT-1 and prognosis
Level of WT1 mRNA and prognosis


Management information

Registered date

2021 Year 09 Month 16 Day

Last modified on

2022 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name