Study on Stopping Chemotherapy in Patients with Acute Myeloid Leukemia (AML) in Remission

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06511882

This clinical trial is exploring whether patients with Acute Myeloid Leukemia (AML) who have been successfully treated with azacitidine or decitabine and venetoclax can safely stop their chemotherapy after a year without increasing the risk of their cancer returning.

Patient Parameters

Program Overview

The aim of this study is to determine if patients with Acute Myeloid Leukemia (AML) who have been effectively treated with a combination of azacitidine or decitabine and venetoclax can discontinue their chemotherapy after one year without a higher chance of the leukemia coming back. This research is focused on patients whose AML is in remission and who have no measurable disease left.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with Acute Myeloid Leukemia (AML), excluding a specific subtype known as M3.
  • Have a performance status score of 2 or less, indicating they are in good enough health to participate.
  • Currently receiving first-line treatment with azacitidine or decitabine and venetoclax, and have achieved complete remission with no detectable disease.
  • Within 12 months of starting the treatment.
  • Not eligible for or have declined a bone marrow transplant.
  • Able to understand and willing to sign a consent form.
  • Agree to follow the study schedule and requirements.
  • Able to provide bone marrow samples for testing during the study.

Exclusion Criteria

  • Have used other chemotherapy or experimental drugs for AML within 28 days before the study starts, except for those on azacitidine or decitabine and venetoclax. Use of hydroxyurea before remission is allowed.
  • Have serious medical conditions or uncontrolled illnesses, such as active infections, heart failure, unstable chest pain, irregular heartbeats, or mental health issues that could interfere with the study or pose a risk.
  • Have a TP53 gene mutation at diagnosis.
  • Have AML that has spread outside the bone marrow, including to the brain or skin, requiring specific treatment at the time of joining the study.
  • Are pregnant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.