Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
NCT ID: NCT00118326
Last Updated: 2010-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
2003-08-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
NCT00450450
G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders
NCT00253552
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
NCT00001529
Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)
NCT00231309
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
NCT01149096
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Determine the safety and feasibility of filgrastim (G-CSF)-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease.
Secondary
* Determine the time to neutrophil and platelet engraftment, number of red blood cell and platelet transfusions, number of febrile days, and number of hospitalization days in patients treated with this regimen.
* Determine the number of nucleated cells and CD34-positive cells, absolute lymphocyte count, and lymphocyte subsets (CD3/CD4/CD8) in G-CSF-mobilized bone marrow from these donors.
OUTLINE: This is a multicenter, pilot study.
Donors receive filgrastim (G-CSF) subcutaneously once daily on days -4 to 0. Donors then undergo standard bone marrow harvest on day 0.
Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis according to the disease for which the patient is being treated and the treatment plan or clinical trial for which the patient is enrolled on. Patients undergo allogeneic bone marrow transplantation on day 0.
After completion of bone marrow harvest, donors are followed at 7 and 30 days. After completion of study treatment, patients are followed for 100 days post-transplantation and then periodically thereafter.
PROJECTED ACCRUAL: A total of 80 participants (40 donors and 40 patients) will be accrued for this study within 18 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
filgrastim
allogeneic bone marrow transplantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fred Hutchinson Cancer Center
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ann E. Woolfrey, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FHCRC-1802.00
Identifier Type: -
Identifier Source: secondary_id
PBMTC-STC0233
Identifier Type: -
Identifier Source: secondary_id
CDR0000430709
Identifier Type: REGISTRY
Identifier Source: secondary_id
1802.00
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.