UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012957 |
|---|---|
| Receipt number | R000015137 |
| Scientific Title | Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma |
| Date of disclosure of the study information | 2014/01/25 |
| Last modified on | 2014/01/25 09:52:46 |
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Basic information
Public title
Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma
Acronym
CLOBRZ study
Scientific Title
Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma
Scientific Title:Acronym
CLOBRZ study
Region
| Japan |
Condition
Condition
Relapsed low grade B cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 2 or 3 courses of chemotherapy followed by 90Y-Iburitumomab tiuxetan for relapsed low grade lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
CR rate
Key secondary outcomes
Completion rate, PFS, TTNT(Time to next treatment)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2~3 courses of chemotherapy followed by Y90-Ibritumomab tiuxetan
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Relapsed low grade lymphoma patients who require treatment
Measurable lymphoma lesion that is more than 2cm
PS 0~2
Key exclusion criteria
Uncontrollable severe complications
Neutrophils <1200/ul, Platelets <100000/ul
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fukuda |
Organization
Tokyo Medical and Dental University
Division name
Department of Hematology
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo
TEL
81-3-5803-5211
fuku.hema@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fukuda |
Organization
Tokyo Medical and Dental University
Division name
Department of Hematology
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo
TEL
81-3-5803-5211
Homepage URL
fuku.hema@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
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 | 25 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | 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
| 2014 | Year | 01 | Month | 25 | Day |
Last modified on
| 2014 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015137
