Status:
COMPLETED
Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)
Lead Sponsor:
Emory University
Conditions:
Hematologic Diseases
Hematologic Malignancies
Eligibility:
All Genders
Up to 55 years
Phase:
NA
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 ...
Detailed Description
This study is a single-arm, non-randomized trial. Patients meeting the criteria for this study will be entered sequentially until completion or closure of the study. Early stopping rules will be emplo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00231309
Start Date
July 1 2003
End Date
November 1 2011
Last Update
August 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Healthcare of Atlanta/Emory University
Atlanta, Georgia, United States, 30322