UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054037 |
|---|---|
| Receipt number | R000061689 |
| Scientific Title | Effects of mobilisation of CD34-positive cells into the peripheral blood after Pegfilgrastim administration and their engraftment on post-transplantation |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2026/04/04 20:40:55 |
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Basic information
Public title
Effects of mobilisation of CD34-positive cells into the peripheral blood after Pegfilgrastim administration and their engraftment on post-transplantation
Acronym
Peg-G 23
Scientific Title
Effects of mobilisation of CD34-positive cells into the peripheral blood after Pegfilgrastim administration and their engraftment on post-transplantation
Scientific Title:Acronym
Effects of mobilisation of CD34-positive cells into the peripheral blood after Pegfilgrastim administration and their engraftment on post-transplantation
Region
| Japan |
Condition
Condition
Haematological malignancies (e.g. leukaemia, malignant lymphoma, multiple myeloma, myelodysplastic syndrome, myeloproliferative disorders)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine factors influencing post-transplantation and engraftment of peripheral blood stem cells mobilised with G-CSF or Pegfilgrastim.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of engraftment rates after allogeneic transplantation between G-CSF and pegfilgrastim.
Key secondary outcomes
<Recipient>.
1 Adverse events after stem cell infusion
2 Failure of engraftment
3 Time from infusion to blood cell engraftment
4 Rate and duration of blood cell engraftment by disease
5 Blood cell engraftment rate and duration by pre-transplant treatment 6 Blood cell engraftment rate and duration by number of stem cells infused 7 Blood cell engraftment rate and duration by GVHD prophylaxis
<Donor
1 CD34-positive cells mobilised into peripheral blood after G-CSF administration
2 Adverse events after G-CSF administration
3 Number of harvested stem cells by G-CSF
4 Fractionation of harvested stem cells by G-CSF
5 Differences in the number of stem cells collected on different collection days (e.g. day4 or day5) 6 Differences in collection efficiency due to differences in collection equipment and settings
7 Relationship between changes in blood levels of cytokines and adverse events
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Recipient>.
1 Persons aged 18 years or older at the time consent is obtained.
2 Performance Status (PS) 0-2 (Ref. 1)
3 After receiving a full explanation of their participation in the study, and with full understanding, the research subject's own
1
Persons who have given their free and voluntary consent <donor
1 Persons who are at least 18 years of age at the time consent is obtained.
2 Persons who perform peripheral blood stem cell collection in daily medical practice
3 Persons who are considered to require daily G-CSF or pegfilgrastim administration for peripheral blood stem cell collection
3 Persons for whom daily G-CSF or pegfilgrastim administration is considered necessary for peripheral blood stem cell collection
4 Persons who, after receiving a full explanation and with full understanding, have given their free and voluntary consent to participate in this study.
4 Persons who, after full explanation of their participation in the study, have given their free and voluntary consent based on a thorough understanding of the situation.
Key exclusion criteria
<Recipient>.
1 Persons who are considered to be at high risk of failure to thrive (as judged by the attending physician). 2 Other persons deemed unsuitable as research subjects by the principal investigator.
<Donor
1 Persons who are deemed ineligible during the preoperative medical examination.
2 Other persons deemed unsuitable as research subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Goto |
Organization
Hokkaido University Hospital
Division name
Division of laboratory and transfusion medicine
Zip code
0608648
Address
N15, W7 Kita-ku Sapposo Hokkaido Japan
TEL
0117067214
hidekigt@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Goto |
Organization
Hokkaido University Hospital
Division name
Division of laboratory and transfusion medicine
Zip code
0608648
Address
N15, W7 Kita-ku Sapposo Hokkaido Japan
TEL
0117067214
Homepage URL
hidekigt@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
N15, W7 Kita-ku Sapposo Hokkaido Japan
Tel
0117067214
hidekigt@med.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://yuketsu.jstmct.or.jp/wp-content/uploads/2025/06/bc70a6c0fc29392aeb356fd725cfe28f.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://yuketsu.jstmct.or.jp/wp-content/uploads/2025/06/bc70a6c0fc29392aeb356fd725cfe28f.pdf
Number of participants that the trial has enrolled
60
Results
There were no significant differences in donor body weight or body surface area between the DailyG and PegG groups. The median peripheral blood CD34 positive cell count on the day of collection was 82.8 per uL range, 16.4 to 174.4 per uL in the DailyG group and 65.8 per uL range, 33.0 to 222.9 per uL in the PegG group.
Results date posted
| 2026 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy volunteer donor
Participant flow
Donors were enrolled at the participating institutions
Adverse events
Pain was the most frequent adverse event in both groups and was generally grade 2 or lower. One case of grade 3 hypertension was observed in the Daily-G group, and one case of grade 3 liver dysfunction was observed in the Peg-G group; both improved at postoperative follow-up.
Outcome measures
There were no significant differences in donor body weight or body surface area between the DailyG and PegG groups. The median peripheral blood CD34 positive cell count on the day of collection was 82.8 per uL range, 16.4 to 174.4 per uL in the DailyG group and 65.8 per uL range, 33.0 to 222.9 per uL in the PegG group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061689
