UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012546 |
|---|---|
| Receipt number | R000014682 |
| Scientific Title | Autologous peripheral blood stem cell transplantation as consolidation for high risk diffuse large B-cell lymphoma:A phase II study |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2021/06/18 12:00:56 |
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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
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
byoin@hospital.city.nishiwaki.hyogo.jp
Sponsor or person
Institute
Nishiwaki Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
