UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000000645
Receipt number	R000000779
Scientific Title	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Date of disclosure of the study information	2007/03/19
Last modified on	2014/10/06 16:07:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Acronym

AML-P05

Scientific Title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Scientific Title:Acronym

AML-P05

Region

Japan

Condition

Acute promyelocytic leukemia

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate an efficacy and safety of the treatment strategy consisted of 5 courses of multi-agent chemotherapy including ATRA, anthracyclines and cytarabine, followed by single-agent maintenance therapy of ATRA

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Three-year event-free survival rate

Key secondary outcomes

Remission induction rate
Three-year overall survival rate
Rate of adverse events
Rate of DIC or retinoic acid syndrome in the first remission induction therapy
Rate of mortality in the first remission induction therapy
Three-year CNS relapse rate

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Five courses of multi-agent combination chemotherapy (2 courses for remission induction and 3 for intensification) consisted of ATRA, anthracyclines, and cytarabine, followed by single-agent maintenance chemotherapy of ATRA for all the eligible patients.

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

18 years-old >

Gender

Male and Female

Key inclusion criteria

Patient with a diagnosis of APL
Genetically or cytogenetically diagnosed by either one of three examination; chromosome, FISH, or southern blot
Age less than 18 years old
ECOG performance status score of 0-2, or of 3 when caused by leukemia
No previous treatment
Sufficient hepatic, renal, and cardiac function
Possible clinical observation for more than 3 years
Written informed consent obtained from guardians

Key exclusion criteria

CNS hemorrhage which is likely to interfere protocol therapy
Secondary APL due to previous chemotherapy or radiation therapy
Unmanageable infectious disease including tuberculosis
Pregnancy
Septic shock
History of organ transplantation
History of congenital or acquired immunodeficiency
Any inappropriate status judged by physician

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hiroyuki Takahashi

Organization

Toho University

Division name

Department of Pediatrics

Zip code

Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451

TEL

03(3762)4151

Email

taccn@fb3.so-net.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Tetsuya Takimoto

Organization

JPLSG

Division name

Deta Center

Zip code

Address

National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya

TEL

052(951)1111

Homepage URL

http://www.jplsg.jp/

Email

jplsgdata@nnh.hosp.go.jp

Sponsor or person

Institute

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Institute

Department

Personal name

Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2007 Year 03 Month 19 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

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

2005 Year 11 Month 29 Day

Date of IRB

Anticipated trial start date

2006 Year 04 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2007 Year 03 Month 17 Day

Last modified on

2014 Year 10 Month 06 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000779

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name