Study on Improving Risk Assessment in AML Using Precision Genomic Strategy to Check Mutation Clearance

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT02756962

This study aims to see if patients with Acute Myeloid Leukemia (AML) who clear their leukemia-related mutations have better survival rates after standard chemotherapy compared to those who don't. It will also explore treatment options for patients with persistent mutations.

Patient Parameters

Parameter	Options

Program Overview

The study is designed to find out if patients with Acute Myeloid Leukemia (AML) who have cleared their leukemia-associated mutations have better chances of staying cancer-free and surviving longer after receiving standard chemotherapy. It will also look at the outcomes for patients who still have these mutations. Since patients with persistent mutations are expected to have a higher chance of relapse, they may receive either standard chemotherapy or a stem cell transplant, depending on their doctor's decision.

Eligibility Criteria

Inclusion Criteria

Aged between 18 and 60 years.
Suitable for intensive chemotherapy treatment.
Have newly diagnosed, untreated AML (not the M3 type) with intermediate-risk disease or normal genetics with specific mutations.
Have completed initial chemotherapy treatment.
In complete remission with some blood count recovery or complete remission after up to two rounds of initial treatment.
Must agree to genetic testing and data sharing, with consent to be informed of any significant genetic findings.
Women and men must use effective birth control during the study.
Must understand and agree to the study's requirements and sign a consent form.
Willing to follow the treatment plan based on mutation levels.

Exclusion Criteria

Have a specific type of leukemia called acute promyelocytic leukemia (APL).
Developed AML due to previous cancer treatments.
Have AML that developed from another blood disorder.
Have medical or social issues that prevent following the study.
Have active infections like HIV, hepatitis B, or hepatitis C (except if positive due to vaccination).
Have allergies to similar medications used in the study.
Are pregnant or breastfeeding. Women must have a negative pregnancy test before joining.

Locations

FACILITY	ZIP	CITY	STATE
University of Florida	32608	Gainesville	Florida
Washington University School of Medicine	63110	St Louis	Missouri
University of Rochester	14642	Rochester	New York

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