UMIN-CTR Clinical Trial

Public title

Positron emission tomography (PET) guided therapy of diffuse large B-cell non-Hodgkin's lymphoma (DLBCL) with or without high dose chemotherapy followed by autologous stem cell transplantation (HDC/ASCT)

Acronym

JSCT-NHL10

Scientific Title

Positron emission tomography (PET) guided therapy of diffuse large B-cell non-Hodgkin's lymphoma (DLBCL) with or without high dose chemotherapy followed by autologous stem cell transplantation (HDC/ASCT)

Scientific Title:Acronym

JSCT-NHL10

Region

Japan

Condition

Diffuse large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to determine whether a PET scan after 2 cycles of R-CHOP can help guided therapy for patients with high-intermediate or high risk DLBCL.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression-free survival at 2 years of patients with a persistently positive PET scan after 2 cycles of R-CHOP

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

Patients who have a positive PET scan after 2 cycles of R-CHOP will receive total 6 cycles of standard R-CHOP followed by HDC/ASCT.

Interventions/Control_2

Patients who have a negative PET scan after 2 cycles of R-CHOP will complete treatment with total 8 cycles of standard R-CHOP.

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

15

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Newly diagnosed NHL by tissue biopsy; DLBCL, listed under mature B-cell neoplasms according to the WHO classification (diffuse large B-cell lymphoma/NOS, primary mediastinal large B-cell lymphoma, excluding intravascular large B-cell lymphoma).
2.Histologically proven CD20 positive DLBCL.
3.Patients with measurable disease by CT scan.
4.Age: 15-65.
5.Ann Arbor stage: 2-4.
6.Performance status (ECOG): 0-3.
7.Age-adjusted International Prognostic Index (aaIPI): High or High-intermediate.
8.Adequate hematological, hepatic, renal, cardiac, or pulmonary function (Neutrophil count >=1000/mm3, Platelet count >=7.5X104/mm3, AST<=3 X upper limit of normal, ALT<=3 X upper limit of normal, T. Bil<=2.0mg/dL, Cr<=2.0mg/dL, EF>=50%, PaO2>=60 mmHg or SaO2>=90%).
9.Patients without severe complications.
10.The patient must sign the consent form prior to registration. If the patient is under age, both the guardian and the patient must sign the consent form.

Key exclusion criteria

1.Patients with a history of prior or concurrent malignancies.
2.Patients who are on any medication for diabetes.
3.Patients who have severe complications such as active systematic infection, heart failure, respiratory failure, pulmonary disease, hepatic failure, liver cirrhosis, acute or chronic hepatitis, renal failure, active tuberculosis.
4.Patients with a history of angina or cardiac infarction. Patients with cardiomyopathy. Patients taking anti-arrhythmic drugs.
5.Patients with a history of drug anaphylaxis.
6.Patients with severe mental illness.
7.Patients with a history of lymphoma, leukemia, or MDS.
8.Patients with a history of chemotherapy, cytokine therapy, or antibody therapy for present DLBCL.
9.Patients with primary central nervous system lymphoma or with central nervous system involvement of DLBCL
10.Pregnancy or lactation.
11.Known hepatitis B or C virus infection
12.Known HIV or HTLV-1 infection
13.Patients with any medical condition that in the opinion of the investigator would compromise treatment delivery.

Target sample size

68

Name of lead principal investigator

1st name
Middle name
Last name	Koji Kato

Organization

Kyushu Univ. Hospital

Division name

Department of Hematology

Zip code

Address

Fukuoka, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

JSCT

Division name

NHL10 datacenter

Zip code

Address

TEL

Homepage URL

Email

jsct-office@umin.ac.jp

Institute

Japan Study Group for Cell Therapy and Transplantation

Institute

Department

Personal name

Organization

Resarch Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

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

2010

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2010

Year

10

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

10

Month

20

Day

Last modified on

2017

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005278