Stopping chemotherapy for patients with Acute Myeloid Leukemia after successful treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether patients with Acute Myeloid Leukemia (AML) who have achieved complete remission can safely discontinue treatment with hypomethylating agents and venetoclax after one year without increasing the risk of relapse. The study focuses on adults who have been on frontline therapy and have shown measurable residual disease negativity. Participants will be monitored to assess the impact of treatment discontinuation on their disease status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults 18 years of age or older at the time of obtaining informed consent.
* Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO)
* Eastern Cooperative Group (ECOG) performance status score ≤ 2
* Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as \< 0.1% by Multiparameter Flow Cytometry (MFC)
* Within 12 months of starting HMA (azacitidine or decitabine)/VEN
* Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
* Ability to understand and the willingness to sign a written informed consent document
* Must agree to adhere to the study visit schedule and other protocol requirements
* Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure

Exclusion Criteria:

* Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed.
* Any serious medical condition or uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or will place the subject at unacceptable risk if he/she participates in the study. Controlled infections or other medical conditions on long-term therapy is allowed.
* Patients who harbored TP53 mutation at diagnosis
* AML with extramedullary involvement including central nervous system (CNS) involvement, myeloid sarcoma, and leukemia cutis requiring directed therapy at the time of enrollment.
* Patient is pregnant.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Onyee Chan, MD — Moffitt Cancer Center
• Study coordinator: Gina Bellenger
• Email: Gina.Bellenger@moffitt.org
• Phone: 813-745-6138

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.