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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043840
Receipt No. R000050034
Scientific Title General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/19

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Basic information
Public title General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-
Acronym General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-
Scientific Title General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-
Scientific Title:Acronym General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-
Region
Japan

Condition
Condition Relapsed or refractory diffuse large B-cell lymphoma
Classification by specialty
Medicine in general Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate incidence proportion and incidence rate of adverse drug reactions (ADRs) in actual clinical use of POLIVY for intravenous infusion 30mg and 140mg (polatuzumab vedotin [genetical recombination]) (hereinafter], POLIVY) for relapsed or refractory diffuse large B-cell lymphoma.
Safety specification: myelosuppression, neuropathy, infections, infusion reaction, progressive multifocal leukoencephalopathy, tumour lysis syndrome, and hepatic function disorder
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major surveillance items, etc.
1) Institution information
Name of institution, name of department, name of physician
2) Patient demographics
Patient initials, age at treatment initiation, ID number, reason for use, history of hypersensitivity to the ingredients of POLIVY, sex, pregnancy, date of initial diagnosis, height, weight, performance status (ECOG PS), NCCN-IPI (NCCN-International Prognostic Index), disease stage classification, treatment line, previous disease, concurrent disease
3) Previous treatment
(Yes/No), and if yes: Name of chemotherapy (rituximab + CHOP, high-dose chemotherapy with autologous hematopoietic stem cell transplantation, salvage chemotherapy, radiation therapy, other)
4) POLIVY treatment status
Dose per administration, administration date, status at completion of observation period (ongoing, suspended, discontinued [reason for discontinuation in patients who discontinued treatment], completed)
5) Concomitant chemotherapy
(Yes/No), and if yes: Name of chemotherapy (bendamustine, rituximab, other), therapy
start date, therapy stop date
6) Prophylaxis treatment for infections
(Yes/No), and if yes: Drug name, treatment start date, treatment end date
7) Adverse event
(Yes/No), and if yes: adverse event name, date of onset, worst grade, seriousness, action taken (POLIVY, other), outcome, date of outcome, causal relationship (POLIVY, other factors)
If serious, comments and laboratory test values related to adverse event
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients eligible for enrollment: All patients expected to receive POLIVY during the enrollment period.
All patients who have participated in clinical trials of POLIVY will be subject for all-patient surveillance from the date of administration of the marketed POLIVY for intravenous infusion 30 mg and 140 mg.
Key exclusion criteria None
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Nomura
Organization Chugai Pharmaceutical Co. Ltd
Division name Drug safety division
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0769
Email nomuramkt@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Ryousue
Middle name
Last name Harada
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real World Data Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0769
Homepage URL
Email haradarus@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email None

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
2021 Year 05 Month 19 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
2021 Year 03 Month 23 Day
Date of IRB
2021 Year 03 Month 23 Day
Anticipated trial start date
2021 Year 05 Month 19 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 04 Month 05 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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