UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study

Acronym

Clinical trial of advanced stage childhood lymphoblastic lymphoma

Scientific Title

Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study

Scientific Title:Acronym

Clinical trial of advanced stage childhood lymphoblastic lymphoma

Region

Japan

Condition

Advanced stage lymphoblastic lymphoma of children.

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To establish the standard therapy in children with advanced stage lymphoblastic lymphoma.To evaluate the efficacy and safety of BFM type chemotherapy in children with advanced stage lymphoblastic lymphoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

3 year event-free survival

Key secondary outcomes

(1) 3year overall survival
(2)Incidence of therapy-rerated severe toxicity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment regimen has fundamentally BFM backbone and intensified with pulse type early and late maintenance phase, which consisted with MTX, VCR, L-ASP, PSL, 6MP, and CPA.

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

1

years-old

<=

Age-upper limit

18

years-old

>

Gender

Male and Female

Key inclusion criteria

Newly diagnosed patients with advanced stage T and B cell lymphoblastic lymphoma

Key exclusion criteria

1, Down's syndrome
2, previous malignancy of any type
3, Prior stem cell or organ transplantation
4, Congenital or acquired immunodeficiency

Target sample size

124

Name of lead principal investigator

1st name	shosuke
Middle name
Last name	Sunami

Organization

Japanese Red Cross Narita Hospital

Division name

Department of Pediatrics

Zip code

2868523

Address

90-1 Iidacho Narita city Japan

TEL

0476222311

Email

s-sunami@sc4.so-net.ne.jp

Name of contact person

1st name	shosuke
Middle name
Last name	Sunami

Organization

Japanese Red Cross Narita Hospital

Division name

Department of Pediatrics

Zip code

2868523

Address

90-1 Iidacho Narita city Japan

TEL

0476222311

Homepage URL

http://www.jplsg.jp:80/

Email

s-sunami@sc4.so-net.ne.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

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)

Address

Santomauro Naka Nagoya City

Tel

0529511111

Email

officejp@nnh.hosp.go.jp

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

2009

Year

07

Month

26

Day

URL releasing protocol

Pediatr Blood Cancer. 2016 Mar;63(3):451-7.

Publication of results

Unpublished

URL related to results and publications

Pediatr Blood Cancer. 2016 Mar;63(3):451-7.

Number of participants that the trial has enrolled

136

Results

The 5-year EFS according to clinical stage in patients with T-cell LBL
(T-LBL) was 70.6% for stage 3 and 88.9% for stage 4 (P = 0.037).
5-year OS was 82.9%, and 5-year EFS was 77.9%.

Results date posted

2025

Year

11

Month

01

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Children age, 1-18 years with newly diagnosed advanced
stage LBL (Murphy stage 3 and 4) were enrolled in the JPLSG ALB-NHL03 study.
Patients with primary immunodeficiencies, Down syndrome, history of cancer, and previous stem cell or organ transplantation were excluded.

Participant flow

The ethics committee of each participating institute approved the study protocol. The diagnosis of LBL was based on histopathology and immunocytochemistry. All histopathological specimens were first classified by the World Health Organization (WHO) classification by the institutional pathologist and then by seven
pathologists from a central pathological review committee.
Staging was made according to Murphys classification, but stage 4 patients with more than 25% blast cells in bone marrow
(BM) were excluded. Initial central nervous system (CNS) disease was diagnosed by the detection of CNS infiltrates on computed tomography (CT) or magnetic resonance imaging, or by the presence of lymphoblasts in the cerebrospinal fluid (CSF).
Between November 2004 and January 2010,154 cases of newly diagnosed LBL were enrolled in this study. Of these, 18 cases were excluded: 12 due to ineligible pathology, three for late enrollment, one for protocol violation, one for LBL from
myelodysplastic syndrome, and one for prior chemotherapy. A total of 136 cases were analyzed

Adverse events

Toxicity was evaluated by the scale of National Cancer
Institute-Common Toxicity Criteria (NCI-CTC) version 2.0.
During the induction phase, grade 4 pancreatitis occurred in
four patients, CNS bleeding occurred in two patients, and acute
appendicitis occurred in one patient. Severe liver dysfunction
similar to veno-occlusive disease was noted in one case.
In pro tocol M, one patient experienced severe MTX-related toxicity
(kidney dysfunction). In the early-maintenance phase, one patient
died of a septic shock with Streptococcus oralis. Relatively
nonsevere toxicities, such as hyperlipidemia and hyperglycemia,
were reported. After completion of the regimen, one case of
colon cancer in the context of familial adenomatous polyposis
and one case of aseptic necrosis of the femoral head were
noted.

Outcome measures

Final statistical analyses were performed on the basis of data obtained in June 2013.The primary endpoint was 5year EFS, defined as the time the treatment started to the first event (relapse
at any site, death from any causes, or second malignant neoplasm. Induction failure was viewed as having an event on
day 0. For patients who did not experience an event, EFS was
defined as the time to the last follow-up. Overall survival was defined as the time when treatment started to death from any
cause. Cumulative incidence rate of isolated CNS relapse was defined as the time to isolated CNS relapse from diagnosis of LBL
for CNS-negative patients.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2004

Year

10

Month

29

Day

Date of IRB

2004

Year

11

Month

01

Day

Anticipated trial start date

2005

Year

02

Month

01

Day

Last follow-up date

2013

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

07

Month

16

Day

Last modified on

2025

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002718