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CompletedNCT01857336Updated Sep 25, 2020

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

An interventional study of infusion of G-CSF mobilized peripheral harvest in Poor Graft Function, Stem Cell Transplantation and Graft Versus Host Disease, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-09-25.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

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

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's planned enrollment of 20 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • age\<14 years;active GVHD;relapse of underlying disease
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    infusion group

    Patients with PGF were planed to infusion peripheral harvest. The peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor.

    Other: infusion of G-CSF mobilized peripheral harvest

Interventions

  • Otherinfusion of G-CSF mobilized peripheral harvest
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What researchers measure

Primary outcomes

  1. hematological response

    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.

    Time frame: 30 days after infusion

07

Study locations

1 site
  • Peking University Institute of Hematology
    Beijing, Beijing 100044, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01857336
Lead sponsor
Peking University People's Hospital
Responsible party
Xiaojun Huang,MD (Peking University Institute of Hematology, Peking University People's Hospital) — Principal investigator
First posted
May 20, 2013
Start date
Mar 1, 2013
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Sep 25, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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