UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000052251
Receipt number	R000059645
Scientific Title	G-Lasta (pegfilgrastim) Subcutaneous Injection 3.6 mg General use-results survey (all-case survey) -Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation-
Date of disclosure of the study information	2023/09/20
Last modified on	2025/12/02 16:23:56

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Basic information

Public title

G-Lasta (pegfilgrastim) Subcutaneous Injection 3.6 mg
General use-results survey (all-case survey)
-Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation-

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

All donors who have received pegfilgrastim for the first time after the date of approval of the indication "Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation"

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The objective of this survey was to confirm the safety of pegfilgrastim in real-world clinical practice when administered to healthy donors for Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation, and to determine the sufficiency of the collected hematopoietic stem cells for transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Safety
-Incidence of adverse reactions
-Incidence of adverse drug reactions and infectious diseases
-Examination of Safety specifications
-Examination of other adverse events (headache, liver dysfunction, etc.)
-Safety after peripheral blood stem cells collection
-Factors that may affect safety

Key secondary outcomes

Efficacy
-Securing the number of peripheral blood stem cells required for transplantation
-Factors that may influence the evaluation of efficacy

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

All donors who have received pegfilgrastim for the first time after the date of approval of the indication " Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation "

Key exclusion criteria

-The contract with the facility has not been concluded
-Outside the contract period with the facility
-Peripheral blood stem cell collection using a daily G-CSF other than pegfilgrastim*
*Registration is possible if peripheral blood stem cell collection was performed
using a daily G-CSF other than pegfilgrastim in the past.
-This is not the first time to collect peripheral blood stem cells by administration
of pegfilgrastim
-Duplicate registration (already registered)

Target sample size

350

Research contact person

Name of lead principal investigator

1st name Hiroshi

Middle name

Last name Kuwazawa

Organization

Kyowa Kirin Co., Ltd.

Division name

Pharmacovigilance Department

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

+81-70-3143-9628

Email

hiroshi.kuwazawa.wd@kyowakirin.com

Public contact

Name of contact person

1st name Hiroshi

Middle name

Last name Kuwazawa

Organization

Kyowa Kirin Co., Ltd.

Division name

Pharmacovigilance Department

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

+81-70-3143-9628

Homepage URL

Email

hiroshi.kuwazawa.wd@kyowakirin.com

Sponsor or person

Institute

Other

Institute

Department

Personal name

Funding Source

Organization

Other

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

Research Ethical Review Committee of Kyowa Kirin Co., Ltd.

Address

1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan

Tel

03-5205-7202

Email

researchethics.fj@kyowakirin.com

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

2023 Year 09 Month 20 Day

Related information

URL releasing protocol

/https://www.pmda.go.jp/RMP/www/230124/4c691a7a-e

Publication of results

Partially published

Result

URL related to results and publications

https://www.jshem.or.jp/87/web.html

Number of participants that the trial has enrolled

403

Results

In terms of PBSC mobilization and collection in healthy donors, Peg-G could be considered a useful option from the viewpoint of donor convenience. Meanwhile, it is essential to provide sufficient information to donors about the risk of serious ADRs to ensure a safety management system at each facility.

Results date posted

2025 Year 11 Month 19 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2025 Year 10 Month 12 Day

Baseline Characteristics

The 403 related donors were enrolled in this survey, with 219 males and 184 females. Median age was 38 (range:16-66) years.

Participant flow

This all-case surveillance was designed as a non-interventional observational study, enrolling all donors who received the drug for the first time on or after February 25, 2022 (the date of approval).
Donors who underwent peripheral blood stem cell collection using G-CSF preparations other than this drug, or who had previously undergone peripheral blood stem cell collection following administration of this drug, were excluded from enrollment. Furthermore, donors without peripheral blood stem cell collection data were excluded from efficacy analysis.
The target number of enrolled donors was 350 (330 donors for safety analysis).
This survey complied with the "Ministry of Health, Labour and Welfare Ordinance on Standards for Conducting Post-Marketing Surveillance and Studies of Pharmaceuticals (GPSP)" (Ministry of Health, Labour and Welfare Ordinance No. 171, dated December 20, 2004), and was conducted with the approval of each facility director.

Adverse events

Adverse drug reactions (ADRs) occurred in 66.5% of the donors, and the main ADRs were back pain, bone pain, and headache. Serious ADRs were observed in 3 donors, including 1 eyelid edema, 1 sudden hearing loss, and 1 aortitis/pyrexia.

Outcome measures

PBSC collection was performed in 401 donors, starting on day 4 (n=3) or day 5 (n=348).Of these, 45 cases required a second and 1 case required a third collection.The median number of CD34+cells in peripheral blood on the day of collection was 82.9/uL (1.9-282.0), and the number of collected CD34+cells was 5.78 (0.67-45.12) x 106/kg recipient weight.CD34+cells collection exceeding 2 x 106/kg was not achieved in 10 cases.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2022 Year 02 Month 21 Day

Date of IRB

2023 Year 08 Month 17 Day

Anticipated trial start date

2022 Year 02 Month 25 Day

Last follow-up date

2024 Year 08 Month 27 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This survey is general use results survey (All Cases Survey) based on the ministerial ordinance on implementation of Good Post-marketing Study Practice.

Management information

Registered date

2023 Year 09 Month 20 Day

Last modified on

2025 Year 12 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059645