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Trial Title:
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD
NCT ID:
NCT06511882
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Decitabine
Venetoclax
Conditions: Keywords:
AML
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Standard of Care Intravenous (IV) infusion
Arm group label:
Consolidation and Discontinuation
Other name:
Vidaza
Intervention type:
Drug
Intervention name:
Decitabine
Description:
Standard of Care Intravenous (IV) infusion
Arm group label:
Consolidation and Discontinuation
Other name:
DACOGEN
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Standard of Care PO (By Mouth)
Arm group label:
Consolidation and Discontinuation
Other name:
Venclexta
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gina Bellenger
Phone:
813-745-6138
Email:
Gina.Bellenger@moffitt.org
Investigator:
Last name:
Onyee Chan, MD
Email:
Principal Investigator
Investigator:
Last name:
Rami Komrokji, MD
Email:
Sub-Investigator
Investigator:
Last name:
Timothy Kubal, MD
Email:
Sub-Investigator
Investigator:
Last name:
Andrew Kuykendall, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jeffrey Lancet, MD
Email:
Sub-Investigator
Investigator:
Last name:
Eric Padron, MD
Email:
Sub-Investigator
Investigator:
Last name:
David Sallman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alison Walker, MD
Email:
Sub-Investigator
Start date:
June 28, 2024
Completion date:
June 2028
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
AbbVie
Agency class:
Industry
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511882
http://www.moffitt.org/clinical-trials-research/clinical-trials/
