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NCT02927938 · ClinicalTrials.gov registry record · Phase 3
Leukemia Stem Cell Detection in Acute Myeloid Leukemia
A Phase 3 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT02927938: Clinical Trial Phase 3 study, sponsored by Wake Forest University Health Sciences.
NCT02927938 is a Phase 3 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02927938, a Phase 3 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment.
Interventions
- PROCEDURE Allogeneic HCT
- DRUG Consolidation chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-09 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 3 |
Why NCT02927938 stopped before completion
NCT02927938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Allogeneic HCT is the first listed.
NCT02927938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02927938 about?
NCT02927938 is a clinical study titled "Leukemia Stem Cell Detection in Acute Myeloid Leukemia". 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 ca...
What is the current status of trial NCT02927938?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2016-09. Estimated completion is 2018-10-05.
What interventions are being tested in trial NCT02927938?
The interventions under investigation include: Allogeneic HCT (PROCEDURE), Consolidation chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02927938?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02927938's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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