UMIN-CTR Clinical Trial

Public title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia

Acronym

AML-05

Scientific Title

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia

Scientific Title:Acronym

AML-05

Region

Japan

Condition

Acute Myeloid Leukemia

Classification by specialty

Hematology and clinical oncology

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate an efficacy and safety of the treatment strategy according to the risk stratification based on leukemia cell biology and response to the initial induction therapy in children less than 18 years old with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (APL), AML with Down syndrome, secondary AML, AML derived from MDS, AML with multilineage dysplasia, NK/myeloid leukemia, and granulocytic sarcoma.

For the Low Risk group (LR), to evaluate an efficacy and safety of the multi-agent combination chemotherapy consisted of 5 courses, including 4 high-dose cytarabine containing courses, reducing anthracyclines and etoposide compared to AML99 study.
For the Intermediate Risk group (IR), to evaluate an efficacy and safety of the intensified multi-agent combination chemotherapy consisted of 5 courses, including 4 high-dose cytarabine containing courses.
For the High Risk group (HR), to evaluate an efficacy and safety of the intensified multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation in first complete remission.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Three-year event-free survival rate of the each risk group

Key secondary outcomes

For the each risk group, 3-year EFS; rate of adverse events defined by Common Terminology Criteria for Adverse Events(CTCAE) ver3.0; compliance rate of protocol specified regimen.

Overall, 3-year EFS and OS; induction remission rate; remission rate after initial course of induction chemotherapy; compliance rate of protocol specified regimen.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Two common courses of remission induction multi-agent combination chemotherapy for all the eligible patients.
For Low Risk group (LR), 3 courses of intensification multi-agent combination chemotherapy.
For Intermediate Risk group (IR), 3 courses of intensification multi-agent combination chemotherapy.
For High Risk group (HR), 1 to 3 courses of intensification multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation.

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

Age-lower limit

Not applicable

Age-upper limit

18

years-old

>

Gender

Male and Female

Key inclusion criteria

1) AML (excluding AML with Down syndrome, APL, secondary AML, NK/myeloid leukemia, and granulocytic sarcoma)
2) age less than 18 years old
3) ECOG performance status score of 0-3
4) no history of previous chemotherapy or radiation therapy
5) sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below;
T-Bil: within 3x of the age-dependent normal range
ALT: within 10x of the institutional normal range
serum creatinine value: within 3x of the age-dependent normal range
ECG:no severe abnormalities (example; QTc>0.45sec)
6)written informed consent obtained from guardians

Key exclusion criteria

1)CNS hemorrhage which is likely to interfere protocol therapy
2)uncontrolled DM
3)severe mental abnormalities
4)pregnancy
5)unmanageable infectious disease
6)history of congenital or acquired immunodeficiency
7)any inappropriate status judged by physician

Target sample size

254

Name of lead principal investigator

1st name
Middle name
Last name	Akio Tawa

Organization

National Hospital Organization Osaka National Hospital

Division name

Department of Pediatrics

Zip code

Address

2-1-14Hoenzaka, Chuo-ku, Osaka city

TEL

06-6942-1331

Email

tawa@onh.go.jp

Name of contact person

1st name
Middle name
Last name	Akio Tawa

Organization

National Hospital Organization Osaka National Hospital

Division name

Department of Pediatrics

Zip code

Address

2-1-14Hoenzaka, Chuo-ku, Osaka city

TEL

06-6942-1331

Homepage URL

http://www.jplsg.jp/

Email

tawa@onh.go.jp

Institute

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

1. CR rate, 3-year EFS and OS rates for the whole cohort (N=443)
CR rate: 86.0%
3-year EFS: 54.3 % (95%CI, 49.3-59.0%)
3-year OS: 73.2 % (95%CI, 68.3-77.4%)
3-year relapse rate: 30.3% (95%CI, 25.9-34.7%)

2. 3-year EFS and OS rates according to the risk group
1) Low risk (LR) group (N=135)
3-year EFS: 69.4 % (95%CI, 60.3-76.8%)
3-year OS: 92.5 % (95%CI, 85.5-96.3%)
2) Intermediate risk (IR) group (N=183)
3-year EFS: 57.3 % (95%CI, 49.3-64.5%)
3-year OS: 73.2 % (95%CI, 65.0-79.8%)
3) High risk (HR) group (N=54)
3-year EFS: 53.4 % (95%CI, 39.2-65.6%)
3-year OS: 66.8 % (95%CI, 51.1-78.4%)

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

Recruitment status

Completed

Date of protocol fixation

2006

Year

04

Month

17

Day

Date of IRB

Anticipated trial start date

2006

Year

11

Month

01

Day

Last follow-up date

2013

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

2012

Year

05

Month

01

Day

Date analysis concluded

2012

Year

06

Month

01

Day

Other related information

Amendment of induction therapy for the patients less than 1 year old at diagnosis:
#1 Unacceptable treatment-related death noted in six of the first 32 infant cases enrolled on JPLSG AML-05 has led to the suspension of study enrollment for the patients less than 1 year of age in April 2nd, 2009.
#2 The JPLSG AML committee has decided to amend the study to reduce the drug doses in the first course of induction therapy and to add a new safety monitoring rules for toxic deaths for the infant cases.
#3 The protocol was amended on August 4th, 2009, and the study enrollment for the patients less than 1 year old at diagnosis was re-started.

Registered date

2006

Year

10

Month

31

Day

Last modified on

2015

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000619