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

Not Applicable

Completed

• Conditions: Stem Cell Transplantation; Poor Graft Function; Graft Versus Host Disease
• Interventions: Other: infusion of G-CSF mobilized peripheral harvest

• Registration Number: NCT01857336
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2013-03-01
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-20
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infusion group	infusion of G-CSF mobilized peripheral harvest	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.

Primary Outcome Measures

Name	Time	Method
hematological response	30 days after infusion	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.

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China