UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015348
Receipt number R000017854
Scientific Title A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Date of disclosure of the study information 2014/10/06
Last modified on 2022/04/11 14:59:23

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Basic information

Public title

A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Acronym

JPLSG AML-P13

Scientific Title

A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Scientific Title:Acronym

JPLSG AML-P13

Region

Japan


Condition

Condition

Acute promyelocytic leukemia

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate an efficacy and safety of the treatment strategy consisted of 2 courses of multi-agent chemotherapy followed by 3 courses of consolidation therapy with either ATO and/or GO.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Three-year event-free survival rate

Key secondary outcomes

Remission induction rate
Molecular remission rate at the end of consolidation therapy
Three-year overall survival rate
Rate of DIC, APL-DS, and mortality during first remission induction therapy
Rate of adverse events during ATO therapy
Rate of adverse events


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

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ALL eligible patients receive 2 courses of induction therapy comprising ATRA, cytarabine and anthracyclines.
Patients who achieved hematological CR (standard risk group) receive 3 courses of consolidation therapy comprising ATRA and ATO, followed by 1 year of maintenance therapy consist of intermittent ATRA.
Patients who did not achieve hematological CR (high risk group) receive 3 courses of consolidation therapy comprising either ATO or GO, followed by 1 year of maintenance therapy consist of 6MP and MTX.
Patients with molecular persistence at the end of consolidation therapy (molecular persistence group) receive single-agent reinduction therapy of GO.

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 methods; karyotyping, FISH, or RT-PCR.
ECOG performance status score of 0-2, or of 3 when caused by leukemia.
No previous treatment.
Written informed consent obtained either from patient or guardians.

Key exclusion criteria

17q12/RARA not detected genetically and cytogenetically
APL with t(11;17)(q23;q12)/PLZF-RARA
CNS hemorrhage which is likely to interfere protocol therapy
Secondary APL due to previous chemotherapy or radiation therapy
Unmanageable infectious disease including tuberculosis
Any inappropriate status judged by physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Takahashi

Organization

Toho University

Division name

Department of Pediatrics

Zip code

143-8451

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 Hiroyuki
Middle name
Last name Takahashi

Organization

Toho University

Division name

Department of Pediatrics

Zip code

143-8451

Address

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

TEL

03(3762)4151

Homepage URL

http://jplsg.jp/

Email

taccn@fb3.so-net.ne.jp


Sponsor or person

Institute

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Institute

Department

Personal name



Funding Source

Organization

Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

Grant from the National Center for Child Health and Development


IRB Contact (For public release)

Organization

Ethics Committee, Toho University Omori Medical Center

Address

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

Tel

03(3762)4151

Email

omori.rinri@ext.toho-u.ac.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

2014 Year 10 Month 06 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

32

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

2014 Year 09 Month 30 Day

Date of IRB

2014 Year 11 Month 14 Day

Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 06 Day

Last modified on

2022 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name