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NCT00357565 · ClinicalTrials.gov registry record · Phase 2
Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00357565 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 34 participants.
The verdict
NCT00357565, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares the patient's bone marrow for the 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 cyclosporine and mycophenolate mofetil may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy followed by a donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia or myelodysplastic syndromes.
Interventions
- DRUG fludarabine phosphate
- DRUG melphalan
- BIOLOGICAL filgrastim
- DRUG busulfan
- DRUG cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-11 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00357565
The ClinicalTrials.gov registry entry for NCT00357565 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00357565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00357565 about?
NCT00357565 is a clinical study titled "Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia". RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused int...
What is the current status of trial NCT00357565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2005-11. Estimated completion is 2025-03-11.
What interventions are being tested in trial NCT00357565?
The interventions under investigation include: fludarabine phosphate (DRUG), melphalan (DRUG), filgrastim (BIOLOGICAL), busulfan (DRUG), cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00357565?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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