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

Completed · Not applicable

Conditions studied: Hematologic Diseases, Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT00231309

Run by

Emory University

People needed

10

Starts

2003-07-01

Expected to finish

2011-11-01

Last updated by the study team

2014-08-22

Who can join

Age: any, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Children's Healthcare of Atlanta/Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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