Primary Objective

Patients with high-risk acute myeloid leukemia (AML) who relapsed or showed a poor response to induction chemotherapy have a dismal prognosis.

The recommended treatment is to pursue a complete remission by means of aggressive reinduction chemotherapy prior to allogeneic transplantation. This approach is associated with potentially life-threatening toxicities and has limited efficacy. As a result, only some patients will reach allogeneic transplantation in complete remission.

To reduce the number of patients who die or who are ineligible for transplantation due to the toxicity of aggressive induction chemotherapy, other bridging options by means of less aggressive chemotherapy or simply monitoring leukemic proliferation can be considered.

Direct comparisons between these two treatment strategies have not been performed. The objective of this trial was to compare outcomes of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy.

Further information can be found at clinicaltrials.gov (NCT02461537) and in the protocol (see downloads below).

Review the practice-changing results for patients with AML here.