UMIN-CTR Clinical Trial

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
Institute	Japan Study Group for Cell Therapy and Transplantation
Institute
Department

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
URL(English)	https://upload.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

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