Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
NCT00450450 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL filgrastim
- PROCEDURE allogeneic bone marrow transplantation
Study Locations (20)
California
- Children's Oncology Group — Arcadia
- University of California San Francisco Medical Center-Parnassus — San Francisco
Indiana
- Indiana University Medical Center — Indianapolis
- Riley Hospital for Children — Indianapolis
Missouri
- The Childrens Mercy Hospital — Kansas City
- Washington University School of Medicine — St Louis
New York
- Roswell Park Cancer Institute — Buffalo
- New York Medical College — Valhalla
Colorado
- Children's Hospital Colorado — Aurora
Illinois
- Childrens Memorial Hospital — Chicago
Kentucky
- Kosair Children's Hospital — Louisville
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-12-31 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00450450
The ClinicalTrials.gov registry entry for NCT00450450 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Juvenile Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which laboratory biomarker analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00450450 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Indiana, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00450450 about?
NCT00450450 is a clinical study titled "Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases". This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growt...
What is the current status of trial NCT00450450?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2007-12-31. Estimated completion is 2022-03-31.
What conditions does trial NCT00450450 study?
This clinical trial studies the following conditions: Juvenile Myelomonocytic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, de Novo Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00450450?
The interventions under investigation include: laboratory biomarker analysis (OTHER), filgrastim (BIOLOGICAL), allogeneic bone marrow transplantation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00450450?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00450450 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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