UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004420
Receipt number R000005278
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)
Date of disclosure of the study information 2010/10/20
Last modified on 2017/10/05 09:52:27

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Basic information

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

Condition

Diffuse large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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



Assessment

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



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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



Public contact

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


Sponsor or person

Institute

Japan Study Group for Cell Therapy and Transplantation

Institute

Department

Personal name



Funding Source

Organization

Resarch Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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

2010 Year 10 Month 20 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name