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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name