NCT00208949

Brief Summary

This is a study involving patients who are undergoing allogeneic peripheral blood stem cell transplantation. Both donors and recipients are being sought for this study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

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

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

September 14, 2012

Status Verified

August 1, 2012

Enrollment Period

7.7 years

First QC Date

September 13, 2005

Results QC Date

March 22, 2012

Last Update Submit

August 17, 2012

Conditions

Hematologic Diseases

Keywords

Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft

    at transplant (1 day)

Secondary Outcomes (1)

  • Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.

    5 years

Study Arms (2)

G-CSF(Granulocyte Colony-Stimulating Factor )

ACTIVE COMPARATOR

Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day

Drug: G-CSF

Granulocyte CSF+Granulocyte Macrophage CSF

ACTIVE COMPARATOR

Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)

Drug: G-CSFDrug: GM-CSF

Interventions

G-CSFDRUG

G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Also known as: Rhu
G-CSF(Granulocyte Colony-Stimulating Factor )Granulocyte CSF+Granulocyte Macrophage CSF
GM-CSFDRUG

GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Also known as: NSC#617589
Granulocyte CSF+Granulocyte Macrophage CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All normal donors for patients undergoing allogeneic peripheral blood stem cell (PBSC) for hematologic diseases will be invited to participate in this research trial.
  • All patients must meet criteria for transplantation.
  • Final eligibility will be determined by the health professionals conducting this clinical trial.

You may not qualify if:

  • Donors for patients undergoing selected or manipulated PBSC grafts are not eligible.
  • Donors who are pregnant or lactating females and donors with a known hypersensitivity to either G-CSF or GM-CSF will be excluded from this study.
  • Final eligibility will be determined by the health professionals conducting this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Granulocyte Colony-Stimulating FactorGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Sagar Lonial
Organization
Emory University
SLONI01@emory.edu
404-778-1900

Study Officials

  • Sagar Lonial, MD

    Emory University Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2002

Primary Completion

May 1, 2010

Study Completion

May 1, 2012

Last Updated

September 14, 2012

Results First Posted

September 14, 2012

Record last verified: 2012-08

Locations

US(1)