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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02927938
Other study ID # LCI-HEM-AML-SCD-001
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2016
Est. completion date October 5, 2018

Study information

Verified date March 2020
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date October 5, 2018
Est. primary completion date October 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Must have previously signed the specimen procurement protocol consent associated with the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML therapy. 2. Age 18 years and older 3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and reviewed by an institutional hematopathologist 4. Completion of induction therapy, as defined by the Investigator and post-induction bone marrow biopsy. Exclusion Criteria: 1. Any debilitating medical or psychiatric illness that would preclude ability to follow study procedures. 2. Indeterminate leukemia stem cell assay results at diagnosis.

Study Design


Intervention

Procedure:
Allogeneic HCT
Allogeneic HCT
Drug:
Consolidation chemotherapy
Cytarabine-based consolidation chemotherapy

Locations

Country Name City State
United States Levine Cancer Institute Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 2 Year Relapse Free Survival (RFS) 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. 2 years
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