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

NCT02756962 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-10-28

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • American Society of Hematology

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Meagan Jacoby, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-06
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02756962 on ClinicalTrials.gov