UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016713 |
|---|---|
| Receipt number | R000019236 |
| Scientific Title | Assessment of time-dependent structural alteration of rituximab in patients |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2019/04/16 14:53:16 |
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Basic information
Public title
Assessment of time-dependent structural alteration of rituximab in patients
Acronym
Assessment of time-dependent structural alteration of rituximab in patients
Scientific Title
Assessment of time-dependent structural alteration of rituximab in patients
Scientific Title:Acronym
Assessment of time-dependent structural alteration of rituximab in patients
Region
| Japan |
Condition
Condition
follicular lymphoma or diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate time-dependent structural alteration of rituximab in patient and its interindividual variability.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma concentration of rituximab and the structural alteration of its carbohydrate chains or other flagments
Key secondary outcomes
In vitro assessment of pharmacological effect of isolated rituximab from patients
Clinical effects (response rate, blood test values, bone marrow infiltration)
Adverse events (clinical test values, presence or absence of infusion reaction)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients diagnosed with follicular lymphoma or diffuse large B-cell lymphoma
Patients who were not treated with rituximab in the past year and will start treatment with one of three regimens containing rituximab (R-CHOP, R-CVP and RB)
Patients who received an explaination of this study and consented it in written form
Key exclusion criteria
Patients who could not be took blood sampling at designated time points
Patients who need legal representative
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Matsubara |
Organization
Kyoto University Hospital
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
606-8507
Address
54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3581
kmatsubara@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yonezawa |
Organization
Kyoto University Hospital
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
606-8507
Address
54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3586
Homepage URL
ayone@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11095-019-2624-5
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood sampling for pharmacokinetic and structural analysis was conducted before and after the administration of rituximab at the day 0, 7, 14 and 21.
Management information
Registered date
| 2015 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019236
