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ACTIVE NOT RECRUITING
NCT02756962
PHASE2

Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2016-07-06

Completion Date

2029-07-31

Last Updated

2025-10-28

Healthy Volunteers

No

Interventions

DRUG

Cytarabine

PROCEDURE

Allogeneic stem cell transplant

PROCEDURE

Bone marrow aspiration

* Baseline * Approximately 30 days after cytotoxic induction therapy * End of treatment

PROCEDURE

Punch skin biopsy

* The first will be obtained with the initial blood and bone marrow collections, whenever possible. * The second will be obtained at the time of re-biopsy to confirm remission.

DEVICE

ClinSeq

Clinical Sequencing to determine clearance or persistence of leukemia-associate mutations performed at MGI CLIA lab

Locations (3)

University of Florida

Gainesville, Florida, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Rochester

Rochester, New York, United States