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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: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00357565 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as achieving donor derived neutrophil count \>500/uL by day 42 in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.
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 |
What the finished NCT00357565 record still lists
NCT00357565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00357565 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00357565's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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