UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000043840
Receipt number	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	2023/11/16 10:32:47

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

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

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

Safety safety division

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3281-6611

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

Safety Science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3281-6611

Homepage URL

Email

haradarus@chugai-pharm.co.jp

Sponsor or person

Institute

Chugai Pharmaceutical Co. Ltd.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 19 Day

Related information

URL releasing protocol

None

Publication of results

Published

Result

URL related to results and publications

None

Number of participants that the trial has enrolled

1877

Results

The incidence rate of ADRs [95% confidence interval (CI)] in the safety analysis set (1827 patients) was 49.15% (46.83 -51.47 patients) (898 patients), and 2217 ADRs occurred.

Results date posted

2023 Year 11 Month 16 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The proportion of male and female subjects was 55.00% (1005 subjects) and 44.99% (822 subjects), respectively, and 1 female subject was pregnant during the treatment period. The mean age [Mean plus minus standard deviation (SD), hereinafter the same] was 73.5 plus minus 10.0 years; there were no subjects aged < 15 years, 13.73% (251 subjects) were aged >- 15 to < 65 years, and 86.26% (1576 subjects) were aged >- 65 years. By line of therapy, 33.55% (613 patients) received the second-line therapy, 26.92% (492 patients) received the third-line therapy, 20.19% (369 patients) received the fourth-line therapy, 18.99% (347 patients) received the others, and 0.32% (6 patients) received unknown/not specified information. The disease stage (Ann Arbor staging system) was I in 5.14% (94 patients), II in 15.32% (280 patients), III in 19.97% (365 patients), IV in 58.83% (1075 patients), unknown/not specified in 0.71% (13 patients), and in NCCN-IPI, low risk in 4.48% (82 patients), low intermediate risk in 17.02% (311 patients), high intermediate risk in 39.57% (723 patients), high risk in 38.31% (700 patients), unknown/not specified in 0.60% (11 patients).
With regard to the presence or absence of prior treatment, 0.21% (4 patients) had no prior treatment, 99.72% (1822 patients) had prior treatment, and 0.05% (1 patient) had no prior treatment, and the status was unknown/not specified etc. Prior treatment (including multiple prior treatments) included rituximab plus CHOP in 1453 patients, high-dose chemotherapy combined with autologous stem cell transplantation in 108 patients, salvage chemotherapy in 766 patients, radiotherapy in 316 patients, others (including salvage chemotherapy other than those described above) in 920 patients, and unknown/not specified etc. in 2 patients.

Participant flow

This surveillance was conducted at 510 contract sites, and 1877 patients were registered from 499 sites during the registration period.
CRFs were collected from 1847 patients at 495 sites because collection became unnecessary or impossible for any of the following reasons: physicians could not cooperate for the survey, patients who received CRFs twice, patients who did not receive CRFs at sites, or patients who did not receive CRFs for other reasons (30 patients).
Of the 1847 patients whose CRFs were collected, 1827 patients were included in the safety analysis set, excluding 14 patients who did not receive polivy, 6 patients whose safety was not confirmed (adverse events), 3 patients with registration violation (patients outside the registration period), and 1 patient with duplication (within the same institution) (including patients with duplication of reasons for exclusion).

Adverse events

Of the 1827 patients in the safety analysis set, the incidence of adverse events was 64.20% (1173 patients) and the number of events was 3151.
Common adverse events (Incidence of adverse events by PT >- 5%) were neutrophil count decreased (19.81%, 362 subjects), platelet count decreased (15.92%, 291 subjects), anaemia (10.12%, 185 subjects), white blood cell count decreased (9.14%, 167 subjects), lymphocyte count decreased (5.36%, 98 subjects), and pyrexia (5.19%, 95 subjects). There was no adverse event unexpected from 'PRECAUTIONS'.

Outcome measures

The incidence rate of ADRs [95% confidence interval (CI)] in the safety analysis set (1827 patients) was 49.15% (46.83 -51.47 patients) (898 patients), and 2217 ADRs occurred.
Major adverse reactions (Incidence of ADRs >- 2% by PT) were neutrophil count decreased in 15.32% (280 patients), platelet count decreased in 12.69% (232 patients), white blood cell count decreased in 7.77% (142 patients), anaemia in 7.60% (139 patients), lymphocyte count decreased in 4.59% (84 patients), febrile neutropenia and neuropathy peripheral in 3.72% (68 patients) each, pyrexia in 3.28% (60 patients), neutropenia in 2.68% (49 patients), decreased appetite in 2.35% (43 patients), and cytomegalovirus infection in 2.18% (40 patients), and none of them was unexpected from 'PRECAUTIONS'.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

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

2023 Year 11 Month 16 Day

Link to view the page

Value
https://center6.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