Clinical Trial 22191

• Overview

  Study Title:

  Discontinuation of Hypomethylating Agent and Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)

  Summary:

  The purpose of the study is to determine if people with Acute Myeloid Leukemia (AML) who are in remission following standard chemotherapy (azacitidine or decitabine given in combination with venetoclax) can stop receiving their chemotherapy for some period of time after a year of treatment without their AML returning.

  Objective:

  Primary objective: To determine CR/CRi at 18 months from the time of initial CR/CRi in patients who discontinue frontline HMA (azacitidine or decitabine)/VEN after achieving MRD negativity by MFC within 12 months of starting therapy. Secondary objectives: To assess OS in MRD-negative patients who discontinue HMA (azacitidine or decitabine)/VEN. To assess MRD-negative CR/CRi and CR/CRi and rates to re-treatment following molecular or morphologic relapse duration discontinuation. To assess duration of TFMR defined as time from MRD negativity to first MRD positivity. To assess changes in QoL and symptoms by EORTC-QLQ-C30 GHS/QoL, PROMIS Fatigue, and EQ-5D-5L VAS.

• Inclusion Criteria

  • Adults 18 years of age or older at the time of obtaining informed consent.
  • Diagnosed with AML (non-M3) as defined by 2016 WHO
  • Eastern Cooperative Group (ECOG) performance status score ≤ 2
  • Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved CR/CRi with MRD negativity defined as > Within 12 months of starting HMA (azacitidine or decitabine)/VEN
  • Ineligible for or declined allogeneic 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 BM aspirate and biopsy specimens for histopathological and MRD 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.

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