UMIN-CTR Clinical Trial

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
Last 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
Email	kmatsubara@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email	ayone@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology & Therapeutics, Kyoto University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019236