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NCT00450450 · ClinicalTrials.gov registry record · Phase 3
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
A Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
- 20
- Study locations
NCT00450450 is a Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 27 participants, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT00450450, a Phase 3 study of Juvenile Myelomonocytic Leukemia and Recurrent Childhood Acute Lymphoblastic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 136-participant average among 11 other Juvenile Myelomonocytic Leukemia trials with a reported enrollment target (80% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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.
NCT00450450 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Indiana, Missouri.
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.
What interventions are being tested in trial NCT00450450?
The interventions under investigation include: laboratory biomarker analysis (OTHER), filgrastim (BIOLOGICAL), allogeneic bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00450450?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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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