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G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation

Infusion of Recombinant Human Granulocyte Colony Stimulating Factor Mobilized Peripheral Harvest for Poor Engraftment After Hematopoietic Stem Cell Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01857336
Enrollment
20
Registered
2013-05-20
Start date
2013-03-01
Completion date
2020-08-31
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease, Poor Graft Function, Stem Cell Transplantation

Brief summary

Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.

Detailed description

Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study.The peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor. Hematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil \> 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.

Interventions

OTHERinfusion of G-CSF mobilized peripheral harvest

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* patients received allogeneic stem cell transplantation;diagnosis of PGF after HSCT; without concurent GVHD,RELAPSE of underlying disease.

Exclusion criteria

* age\<14 years;active GVHD;relapse of underlying disease

Design outcomes

Primary

MeasureTime frameDescription
hematological response30 days after infusionHematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil \> 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026