Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
Public ClinicalTrials.gov record NCT00357565. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia and Myelodysplastic Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00357565
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 34 participants
Conditions and interventions
Conditions
- Leukemia
- Myelodysplastic Syndromes
- Childhood Acute Myeloid Leukemia in Remission
- Recurrent Childhood Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Childhood Acute Lymphoblastic Leukemia in Remission
- Previously Treated Myelodysplastic Syndrome
- Secondary Myelodysplastic Syndrome
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Anemia With Excess Blasts
- Refractory Anemia
- De Novo Myelodysplastic Syndrome
- Childhood Myelodysplastic Syndrome
Interventions
- filgrastim Biological
- busulfan Drug
- cyclosporine Drug
- fludarabine phosphate Drug
- melphalan Drug
- mycophenolate mofetil Drug
- umbilical cord blood transplantation Procedure
Biological · Drug · Procedure
Eligibility (public fields only)
- Age range
- Up to 3 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2005 (Actual)
- Primary completion
- Jun 2024 (Actual)
- Completion
- Mar 11, 2025 (Actual)
- Last update posted
- Aug 26, 2025
2005 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00357565, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00357565 live on ClinicalTrials.gov.