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NCT06511882 | RECRUITING | Acute Myeloid Leukemia

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD
Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:

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.

Condition or disease

Acute Myeloid Leukemia

Intervention/treatment

Azacitidine

Decitabine

Venetoclax

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 37 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-11-07
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2028-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Location Details

NCT06511882

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How to Participate

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Locations

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612