At a glance
ClinicalIndex Comparison Record- ✓Morphologically confirmed AML with >20% blasts in peripheral blood or marrow
- ✓Age 16-60 years
- ✓ECOG performance status 0-4
- ✓LVEF at least 45% by MUGA scan
- ✕Acute promyelocytic leukemia (APL) with t(15;17) or variant t(v;17)
- ✕Secondary AML (chemotherapy-induced or evolved from MDS) or multilineage dysplasia with prior MDS
- ✕Acute panmyelosis with myelofibrosis or blastic transformation of chronic myelogenous leukemia
- ✕Bilirubin >2.0 mg/dL unless due to Gilbert's syndrome or hemolysis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
In Brief
A Phase 3 clinical trial evaluating sargramostim, busulfan, and 6 other interventions for Leukemia. Completed, enrolled 657 participants across 99 sites in 2 countries.
Detailed Summary
RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.
Study Details
Timeline
Interventions
Given IV or as an injection
Given IV
Given IV
Given as a continuous infusion
Given IV
Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
Autologous hematopoietic cell transplantation
Allogeneic hematopoietic cell transplantation