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

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01857336
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 90
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Poor Graft Function; Stem Cell Transplantation; Graft Versus Host Disease	Other: infusion of G-CSF mobilized peripheral harvest	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Infusion of Recombinant Human Granulocyte Colony Stimulating Factor Mobilized Peripheral Harvest for Poor Engraftment After Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 60 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Institute of Hematology	Beijing	Beijing	China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Huang,MD, Peking University Institute of Hematology, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT01857336
• Other Study ID Numbers: 2013-03
• First Posted: May 20, 2013
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Sep 25, 2020