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

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ClinicalTrials.gov Identifier: NCT01857336
Recruitment Status : Recruiting
First Posted : May 20, 2013
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, 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.

Condition or disease Intervention/treatment Phase
Poor Graft Function Stem Cell Transplantation Graft Versus Host Disease Other: infusion of G-CSF mobilized peripheral harvest Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : March 1, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. hematological response [ Time Frame: 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.



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857336


Contacts
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Contact: Yu-Qian SUN, MD sunyuqian83@hotmail.com

Locations
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China, Beijing
Peking University Institute of Hematology Recruiting
Beijing, Beijing, China, 100044
Contact: Yu-Qian SUN, MD       sunyuqian83@hotmail.com   
Principal Investigator: Xiao-Jun HUANG, MD,PhD         
Sponsors and Collaborators
Peking University People's Hospital

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Responsible Party: Xiaojun Huang, Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01857336     History of Changes
Other Study ID Numbers: 2013-03
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic