Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Public ClinicalTrials.gov record NCT00070135. 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 Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well fludarabine and busulfan followed by a donor (allogeneic) stem cell transplant work in treating older patients with acute myeloid leukemia that is in first complete remission. Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stops 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. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus, methotrexate, and rabbit antithymocyte globulin before or after the transplant may stop this from happening.
Study identification
- NCT ID
- NCT00070135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Interventions
- filgrastim Biological
- Anti-Thymocyte Globulin Biological
- busulfan Drug
- fludarabine phosphate Drug
- methotrexate Drug
- tacrolimus Drug
- Allogeneic Hematopoietic Stem Cell Transplantation Procedure
Biological · Drug · Procedure
Eligibility (public fields only)
- Age range
- 60 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
- Jan 2004 (Actual)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Jun 15, 2016 (Actual)
- Last update posted
- Jun 12, 2018
2004 – 2016
United States locations
- U.S. sites
- 21
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber/Brigham and Women's Cancer Center Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | — |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | 11042 | — |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | — |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | — |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | — |
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 NCT00070135, 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 Jun 12, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00070135 live on ClinicalTrials.gov.