NCT00501228

Brief Summary

Primary Objective: 1\. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation. Secondary Objective: 1\. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 20, 2009

Completed
Last Updated

August 7, 2012

Status Verified

July 1, 2012

Enrollment Period

5.6 years

First QC Date

July 12, 2007

Results QC Date

March 3, 2009

Last Update Submit

July 31, 2012

Conditions

Graft-Versus-Host Disease

Keywords

Graft-Versus-Host DiseaseStem Cell TransplantationTissue RepairOrgan-Specific Tissue DamageFilgrastimRhG-CSF

Outcome Measures

Primary Outcomes (1)

  • Number of Donor Derived Cells After G-CSF Therapy

    In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.

    Baseline + 8 Weeks post transplant

Study Arms (1)

Filgrastim Injections

EXPERIMENTAL
Drug: Filgrastim

Interventions

FilgrastimDRUG

5 mg/kg ID Once Daily x 1 Week

Also known as: RhG-CSF
Filgrastim Injections

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
  • Patients should have engrafted with WBC concentration \>3000/ul. Patients should have acute GVHD overall \> grade 2 or chronic GVHD.
  • Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
  • Donors and patients must be of different gender.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
  • The only acceptable consent form is the one attached at the end of this protocol.
  • Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.

You may not qualify if:

  • Patients who are allergic to rhG-CSF.
  • Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Filgrastimpegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

Study was closed because of the very limited number of patients enrolled. Patients eligible for enrollment were not willing to undergo 4 weekly cycles of G-CSF treatment because of the well known side effect of bone pain.

Results Point of Contact

Title
Martin Korbling, MD / Professor
Organization
U.T. M.D. Anderson Cancer Center
713-745-3219

Study Officials

  • Martin J. Korbling, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 16, 2007

Study Start

February 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 7, 2012

Results First Posted

November 20, 2009

Record last verified: 2012-07

Locations

US(1)