At a glance
ClinicalIndex Comparison Record- ✓Acute myeloid leukemia (AML) excluding FAB M3 in first morphologic complete remission
- ✓Preceding myelodysplastic syndrome (MDS) or treatment-related AML eligible
- ✓Prior CNS involvement eligible if in remission at transplant
- ✓CR defined as <5% blasts, ANC >1,000/uL, platelets >100,000/uL, no extramedullary disease, no peripheral blasts
- ✕FAB M3 (acute promyelocytic leukemia) excluded
- ✕Acute leukemia from blast transformation of CML or other myeloproliferative disease excluded
- ✕HIV infection
- ✕Uncontrolled diabetes mellitus or active serious infection requiring antibiotics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen
In Brief
A Phase 2 clinical trial evaluating filgrastim, Anti-Thymocyte Globulin, and 5 other interventions for Adult Acute Myeloid Leukemia in Remission and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome. Completed, enrolled 121 participants across 21 sites.
Detailed Summary
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 Details
Timeline
Interventions
Given SC
Given IV
Given IV
Given IV
Given IV
Given PO or IV
Undergo allogeneic PBSC transplantation