Effects of mobilisation of CD34-positive cells into the peripheral blood after Pegfilgrastim administration and their engraftment on post-transplantation

UMIN ID: UMIN000054037

Registered date:02/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Haematological malignancies (e.g. leukaemia, malignant lymphoma, multiple myeloma, myelodysplastic syndrome, myeloproliferative disorders)
• Date of first enrollment: 2023/04/20
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Comparison of engraftment rates after allogeneic transplantation between G-CSF and pegfilgrastim.
• Secondary Outcome: <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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Hokkaido University Hospital
• Source(s) of Monetary Support: Kyowa Kirin