drugset / Trial / NCT02927938

Leukemia Stem Cell Detection in Acute Myeloid Leukemia

NCT02927938 ↗

Phase 3 Terminated 18 enrolled Wake Forest University Health Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following induction chemotherapy. However, a large majority subsequently relapse and succumb to the disease. Currently, cytogenetics and molecular aberrations are the best prognostic indicators; however, these factors cannot prognosticate accurately for individual patients. Overall, the majority of patients with favorable or intermediate-risk AML will experience relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably translate into cure. This study is undertaken to determine whether the presence of LSCs has prognostic value as well as to determine whether the presence of LSCs has predictive value. This study has an observational component, whereby we intent evaluate whether the presence or absence of LSCs is prognostic. This study also has an interventional component in which it uses LSC status to determine whether favorable and intermediate risk AML patients in CR receive consolidation with chemotherapy or allogeneic HCT.

Timeline

Start
2016-09
Primary completion
2018-10-05
Completion
2018-10-05

Outcome

Outcome not reported

Stopped: “Study terminated 7/23/2019 due to limited participation and testing challenges.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule — —