Back to resultsG-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation
Primary Purpose
Poor Graft Function, Stem Cell Transplantation, Graft Versus Host Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infusion of G-CSF mobilized peripheral harvest
Sponsored by
About this trial
This is an interventional treatment trial for Poor Graft Function
Eligibility Criteria
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
Sites / Locations
- Peking University Institute of Hematology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
infusion group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01857336
First Posted
May 16, 2013
Last Updated
September 23, 2020
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01857336
Brief Title
G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation
Official Title
Infusion of Recombinant Human Granulocyte Colony Stimulating Factor Mobilized Peripheral Harvest for Poor Engraftment After Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Graft Function, Stem Cell Transplantation, Graft Versus Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
infusion group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
infusion of G-CSF mobilized peripheral harvest
Primary Outcome Measure Information:
Title
hematological response
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Learn more about this trial
G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation
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