UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000989
Receipt number R000001191
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia
Date of disclosure of the study information 2008/01/22
Last modified on 2019/01/30 09:47:14

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Basic information

Public title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia

Acronym

AML-D05

Scientific Title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia

Scientific Title:Acronym

AML-D05

Region

Japan


Condition

Condition

Acute myeloid Leukemia
Myelodysplastic syndrome

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 treatment strategy according to the risk stratification based on response to the initial induction therapy on Down syndrome more than 4 months and less than 18 years old with newly diagnosed childhood acute myeloid leukemia(AML) and myelodysplastic syndrome(MDS) excluding acute promyelocytic leukemia(APL). For the Standard Risk group (SR), to evaluate efficacy and safety of the multi-agent combination chemotherapy reducing etoposide compared to AML 99 Down study. For the High Risk group (HR), to evaluate efficacy and safety of the multi-agent combination chemotherapy consisted of continuous and high-dose cytarabine

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Two-year event-free survival rate

Key secondary outcomes

Remission rate after initial induction chemotherapy
Remission rate for high risk group
Three-year overall survival rate
Two-year event free survival for each risk group
Three-year overall survival for each risk group
Incidence of FLT3-ITD
Two-year event free survival with or without FLT3-ITD
Incidence of adverse events during chemotherapy
Compliance rate of protocol specified regimen
Three-year event free survival of the patients less than 4 years old




Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Single common courses of remission induction multi-agent combination chemotherapy for all the eligible patients
For Standard Risk group(SR), 4 courses of intensification multi-agent combination chemotherapy
For High Risk group(HR), 2 courses of remission induction multi-agent combination chemotherapy followed by 4 courses of intensification multi-agent combination chemotherapy

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

4 months-old <=

Age-upper limit

216 months-old >

Gender

Male and Female

Key inclusion criteria

1)AML(excluding APL) and MDS with Down syndrome
2)age more than 4 month and less than 18 years old
3)ECOG performance status score of 0-3
4)no history of previous chemotherapy (except administration of cytarabine for transient myeloproliferative disorder) or radiotherapy
5)sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below:
T-Bil: within 3 times of the age-dependent normal range
serum creatinine value: within 3 times of the age-dependent normal range
ECG: no severe abnormalities (example; QTc >0.45)
6)written informed consent obtained from guardians

Key exclusion criteria

1)CNS hemorrhage which is likely to intervent protocol therapy
2)uncontrolled DM
3)uncontrolled cardiac failure
4)pregnancy
5)unmanageable infectious disease
6)history of congenital or acquired immunodeficiency
7)CNS leukemia
8)any inappropriate status judged by physician

Target sample size

73


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Taga

Organization

Shiga University of Medical Science

Division name

Department of Pediatrics

Zip code


Address

Seta-tsukinowa, Otsu, Shiga

TEL

077-548-2228

Email

ttaga@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Taga

Organization

Shiga University of Medical Science

Division name

Departiment of Pediatrics

Zip code


Address

Seta-tsukinowa, Otsu, Shiga, 520-2192

TEL

077-548-2228

Homepage URL

http://www.jplsg.jp/

Email

ttaga@belle.shiga-med.ac.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

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2008 Year 01 Month 22 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

No longer recruiting

Date of protocol fixation

2007 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 06 Month 30 Day

Date analysis concluded

2014 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2008 Year 01 Month 22 Day

Last modified on

2019 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001191


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name