Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission

Completed · Phase 2

Conditions studied: Adult Acute Myeloid Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00070135

Run by

Alliance for Clinical Trials in Oncology

People needed

121

Starts

2004-01-01

Expected to finish

2016-06-15

Last updated by the study team

2018-06-12

Who can join

Age: 60 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber/Brigham and Women's Cancer Center — Boston, Massachusetts, United States
• Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• Cancer Institute of New Jersey at Cooper - Voorhees — Voorhees Township, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Monter Cancer Center of the North Shore-LIJ Health System — Lake Success, New York, United States
• CCOP - North Shore University Hospital — Manhasset, New York, United States
• Don Monti Comprehensive Cancer Center at North Shore University Hospital — Manhasset, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• New York Weill Cornell Cancer Center at Cornell University — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.