Trials / Terminated
TerminatedNCT02927938
Leukemia Stem Cell Detection in Acute Myeloid Leukemia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Allogeneic HCT | Allogeneic HCT |
| DRUG | Consolidation chemotherapy | Cytarabine-based consolidation chemotherapy |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-10-05
- Completion
- 2018-10-05
- First posted
- 2016-10-07
- Last updated
- 2022-04-21
- Results posted
- 2020-03-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02927938. Inclusion in this directory is not an endorsement.