Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)

NCT00231309 | Completed Results DMC

• 1 other identifier: 0561-2003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The major purpose of this study is to evaluate the curative potential of white cell growth hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients with cancers or blood diseases, who have poor potential for a cure with standard treatment, will be able to participate in the study. Donors will receive the white cell growth hormone (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their bone marrow cells. Total body irradiation and/or chemotherapy will be given first to prepare the patient's body for the infusion of new bone marrow cells from the donor. Two medicines (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells (graft) from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain safety checkpoints were built into the study if unwanted/unexpected events were to occur. If the outcomes appear better than could be expected, this will provide a bridge to extend this current approach for other innovative therapies.

Conditions

Hematologic Diseases; Hematologic Malignancies

Keywords

G-CSF; Bone Marrow; Hematologic malignancies; Non-malignancies; Matched sibling donor; Allogeneic BMT

Outcome Measures

Primary Outcomes (1)

• Numbers of Participants With Disease-free Survival.

  Evaluate the numbers of participants with disease-free survival

  260 days

Secondary Outcomes (1)

• Hospital Length of Stay

  inpatient hospital stay

Study Arms (1)

single arm

OTHER

Drug: Granulocyte Colony Stimulating Factor

Interventions

Granulocyte Colony Stimulating Factor DRUG

Granulocyte Colony Stimulating Factor

single arm

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with hematologic malignancies and non-malignancies who are candidates for matched sibling donor allogeneic bone marrow transplantation are eligible for this study.
• Patients who are under 55 years of age.
• Patients who have a life expectancy of at least 12 weeks and a performance status of at least 2 Zubrod or 70% Karnofsky status prior to transplantation.
• Patients who are acceptable candidates for marrow transplantation based on their pre-BMT evaluation.
• Patients who have available histocompatible siblings who have been medically approved as marrow donors.
• Patients who sign informed consent for the protocol approved by the Institutional Review Board of Emory University/Children's Healthcare of Atlanta.
• Donors must be 5 years of age or older, and have completed routine donor evaluations and signed (by parent or legal guardian) informed consent for the protocol approved by the Institutional Review Board of Emory University/Children's Healthcare of Atlanta.

You may not qualify if:

• Patients will not be excluded based on sex, racial, or ethnic background.
• Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with a successful outcome following bone marrow transplant utilizing the following guidelines:
• Evidence of active, deep seated, life-threatening infections for which there is no known effective therapy (e.g. certain fungal species, HIV, etc.).
• Patients with hemoglobinopathy (e.g. sickle cell disease and thalassemia) will not be eligible for this protocol. However, filgrastim mobilization, large volume apheresis, processing, and cryopreservation appears to be safe in donors with sickle cell trait.
• Patients have had greater than two leukemic episodes, active central nervous system (CNS) and/or leukemic disease and blast crisis in chronic myelogenous leukemia (CML) patients.
• Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-hCG+) or who are not practicing adequate contraception.
• Patients who have had previous stem cell transplant will be excluded.
• Donors will be excluded if they are sensitive to E. coli-derived protein.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta/Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Our study is also limited by its small patient population and short follow-up time.

Results Point of Contact

• Title: Kuang-Yueh Chiang, MD
• Organization: Emory University

kuang-yueh.chiang@choa.org

404-785-1441

Study Officials

• Kuang-Yueh Chiang, M.D.

  Emory University/CHOA

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: July 1, 2003
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 22, 2014
• Results First Posted: August 19, 2014

Record last verified: 2014-08

Locations

US (1)