Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
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|ClinicalTrials.gov Identifier: NCT00118326|
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : May 14, 2010
|First Submitted Date ICMJE||July 8, 2005|
|First Posted Date ICMJE||July 11, 2005|
|Last Update Posted Date||May 14, 2010|
|Study Start Date ICMJE||August 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Safety and feasibility|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00118326 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease|
|Official Title ICMJE||Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant|
RATIONALE: A bone marrow transplant from a brother or sister may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF to the donor may help the body make more stem cells that can be collected for bone marrow transplant and may cause fewer side effects in the patient after the transplant.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Actual Study Completion Date||May 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00118326|
|Other Study ID Numbers ICMJE||1802.00
CDR0000430709 ( Registry Identifier: PDQ )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Fred Hutchinson Cancer Research Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||Fred Hutchinson Cancer Research Center|
|Verification Date||May 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP