Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT01168219. 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
Phase II Study of the Addition of Azacitidine (NSC#102816) to Reduced-Intensity Conditioning Allogeneic Transplantation for Myelodysplasia (MDS) and Older Patients With AML
Study identification
- NCT ID
- NCT01168219
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 68 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia
- Adult Acute Megakaryoblastic Leukemia
- Adult Acute Monoblastic Leukemia
- Adult Acute Monocytic Leukemia
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With Maturation
- Adult Acute Myeloid Leukemia With Minimal Differentiation
- Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
- Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
- Adult Acute Myeloid Leukemia Without Maturation
- Adult Acute Myelomonocytic Leukemia
- Adult Erythroleukemia
- Adult Pure Erythroid Leukemia
- Alkylating Agent-Related Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Myelodysplastic Syndrome With Excess Blasts
- Recurrent Adult Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndrome
- de Novo Myelodysplastic Syndrome
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Anti-Thymocyte Globulin Biological
- Azacitidine Drug
- Busulfan Drug
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Methotrexate Drug
- Pharmacological Study Other
- Tacrolimus Drug
Procedure · Biological · Drug + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 74 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
- Jul 14, 2010
- Primary completion
- Nov 13, 2015
- Completion
- Jan 31, 2020
- Last update posted
- Aug 3, 2022
2010 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Christiana Care - Union Hospital | Elkton | Maryland | 21921 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| Northwell Health NCORP | Lake Success | New York | 11042 | — |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
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 NCT01168219, 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 3, 2022 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01168219 live on ClinicalTrials.gov.