UMIN-CTR Clinical Trial

Basic information
Public title	Autologous peripheral blood stem cell transplantation as consolidation for high risk diffuse large B-cell lymphoma:A phase II study
Acronym	Up-front transplantation for high risk diffuse large B-cell lymphoma:A phase II study
Scientific Title	Autologous peripheral blood stem cell transplantation as consolidation for high risk diffuse large B-cell lymphoma:A phase II study
Scientific Title:Acronym	Up-front transplantation for high risk diffuse large B-cell lymphoma:A phase II study
Region	Japan

Condition
Condition	Diffuse Large B-Cell Lymphoma:IPI high risk group, CR1
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study the safety and efficacy of consolidation therapy a high dose chemotherapy followed autologous peripheral blood stem cell transplantation for high risk diffuse large B-Cell lymphoma which show a complete response by the first-line chemotherapy:(Phase II study)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year disease-free survival and the treatment-related toxicity
Key secondary outcomes	-Relapse rate within one year after the transplant -Non-relapse mortality rate within one-year after the transplant -1-year disease-free survival -2-year overall survival rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A high dose chemotherapy (ex.MCEC) combination therapy followed by autologous peripheral blood 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

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. ECOG 0-1 3. Cardiac: LV Ejection fraction>40% by Echocardiogram 4. Pulmonary: SpO2>94% and FEV1.0%>70%. 5. Hepatic: total bilirubin>2.0mg/dl and AST>2.5x ULN. 6. Renal: Serum creatinine clearance>30ml/min
Key exclusion criteria	1.Drug allergy used for conditioning regimen. 2.Positive HBs antigen or seropositive to HIV.(Not exclude for seropositive to HCV) 3.Uncontrolled infection. 4.Patients inappropriate for transplantation with reasons other than above.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshimitsu Matsui
Organization	Nishiwaki Municipal Hospital
Division name	Department of Hematology
Zip code
Address	652-1, Shimotoda, Nishiwaki, 677-0043 Hyogo, Japan
TEL	81-795-22-0111
Email	t-matsui@nshp.jp

Public contact
Name of contact person	1st name Middle name Last name Takao Kashiwagi
Organization	Nishiwaki Municipal Hospital
Division name	Department of Medicine
Zip code
Address	652-1, Shimotoda, Nishiwaki, 677-0043 Hyogo, Japan
TEL	81-795-22-0111
Homepage URL	http://nshp.jp
Email	byoin@hospital.city.nishiwaki.hyogo.jp

Sponsor
Institute	Nishiwaki Municipal Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	2014 Year 01 Month 06 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	Terminated
Date of protocol fixation	2013 Year 11 Month 26 Day
Date of IRB	2013 Year 11 Month 29 Day
Anticipated trial start date	2014 Year 01 Month 06 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 11 Day
Last modified on	2021 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014682