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

P

Peking University

Status

Completed

Conditions

Stem Cell Transplantation
Graft Versus Host Disease
Poor Graft Function

Treatments

Other: infusion of G-CSF mobilized peripheral harvest

Study type

Interventional

Funder types

Other

Identifiers

NCT01857336
2013-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

14 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

infusion group
Experimental group
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.
Treatment:
Other: infusion of G-CSF mobilized peripheral harvest

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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