A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

NCT00646763 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB000074457445
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Conditions

Cytokines

Outcome Measures

Primary Outcomes (2)

• The Total Number of CD34+ Cells Collected.

  4 days

• Number of Participants for Whom Target Number of CD34+ Cells Were Collected.

  Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 \* 10\^6 cells/kg, a cell dose that consistently results in rapid cell engraftment

  7 days

Secondary Outcomes (1)

• Total Number of Days of Apheresis

  7 days

Study Arms (2)

Abdomen

ACTIVE COMPARATOR

These subjects will have their cytokine injections administered only to their abdomen.

Drug: G-CSF and GMCSF administered at abdomen

Extremities

ACTIVE COMPARATOR

The extremity arm will have their injections administered to their upper and/or lower extremities.

Drug: G-CSF, GM-CSF administered at extremities

Interventions

G-CSF, GM-CSF administered at extremities DRUG

Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.

Also known as: Neupogen, Leukine, growth factors

Extremities

G-CSF and GMCSF administered at abdomen DRUG

Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.

Also known as: Neupogen, Leukine, growth factors

Abdomen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

You may not qualify if:

• Patients with active, invasive/systemic fungal infection.
• Patients who are pregnant or lactating females.
• Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
• Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; sargramostim; Intercellular Signaling Peptides and Proteins

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Edmund Waller, MD, PhD
• Organization: Emory University Winship Cancer Institute

ewaller@emory.edu

1-888-946-7447

Study Officials

• Edmund Waller, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2011
• Last Updated: April 1, 2025
• Results First Posted: May 11, 2012

Record last verified: 2025-03

Locations

US (1)