Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Public ClinicalTrials.gov record NCT00322101. 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
A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also 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. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia. PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Study identification
- NCT ID
- NCT00322101
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 25 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Myelodysplastic Syndromes
- de Novo Myelodysplastic Syndromes
- Myelodysplastic Syndrome With Isolated Del(5q)
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
Interventions
- total-body irradiation Radiation
- allogeneic hematopoietic stem cell transplantation Procedure
- cyclophosphamide Drug
- mycophenolate mofetil Drug
- busulfan Drug
- cyclosporine Drug
- fludarabine phosphate Drug
- peripheral blood stem cell transplantation Procedure
- nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure
- laboratory biomarker analysis Other
- cytogenetic analysis Genetic
- flow cytometry Other
- fluorescence in situ hybridization Genetic
- pharmacological study Other
- polymorphism analysis Genetic
- tacrolimus Drug
- methotrexate Drug
Radiation · Procedure · Drug + 2 more
Eligibility (public fields only)
- Age range
- Up to 65 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
- Dec 31, 2005
- Primary completion
- Mar 31, 2012
- Completion
- Sep 30, 2014
- Last update posted
- Oct 30, 2014
2006 – 2014
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HealthOne Presbyterian St. Lukes Medical Center | Denver | Colorado | — | — |
| Emory University | Altanta | Georgia | 30322 | — |
| Weill Cornell University | New York | New York | 10021 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Veterans Administration Center-Seattle | Seattle | Washington | 98108 | — |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
| Medical College Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00322101, 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 Oct 30, 2014 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00322101 live on ClinicalTrials.gov.