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

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.

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplantation; Graft Versus Host Disease; Poor Graft Function
• Intervention / Treatment: Other: infusion of G-CSF mobilized peripheral harvest

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University Institute of Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after infusion

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (ESTIMATE): May 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 2013-03