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Recruiting NCT06511882

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azacitidine, Decitabine, Venetoclax.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.

Interventions

  • Drug Azacitidine
    Standard of Care Intravenous (IV) infusion
  • Drug Decitabine
    Standard of Care Intravenous (IV) infusion
  • Drug Venetoclax
    Standard of Care PO (By Mouth)

Primary outcome measures

  • Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi) [Time frame: Up to 18 Months]
Secondary outcome measures (6)
  • Overall Survival (OS) [Time frame: Up to 36 Months]
  • Rates to Re-Treatment [Time frame: Up to 36 Months]
  • Treatment Free Molecular Remission (TFMR) [Time frame: Up to 36 Months]
  • European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30)/Quality of Life (QoL) [Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]
  • Patient Reported Outcome Measurement Information System (PROMIS) [Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]
  • EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) [Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Moffitt Cancer Center — Tampa

Identifiers

NCT: NCT06511882 · MCC-22191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗