Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06511882
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 7, 2024
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Consolidation and Discontinuation
    Consolidation: Patient will receive HMA (azacitidine or decitabine)/VEN (venetoclax) as part of standard of care treatment. At the conclusion of consolidation, if the results of the bone marrow biopsy are a negative Measurable Residual Disease (MRD), patient will continue to Discontinuation. Discontinuation: Monthly clinic visits with laboratory assessment and bone marrow biopsies (BMBs) with MRD testing every 3 months to closely monitor disease status. At any point of the study if molecular relapse (including MRD emergence), or morphologic relapse, therapy will be reinitiated. If only molecular relapse, HMA (azacitidine or decitabine)/VEN (venetoclax) will be reinitiated with the same monitoring schedule as before. If morphologic relapse, HMA (azacitidine or decitabine)/VEN (venetoclax) will be reinitiated for 2 cycles. If no response (NR), patient will be taken off Study.

Primary Outcome Measure

Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi) [ Time Frame: Up to 18 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Gina Bellenger
[email protected]
813-745-6138
Onyee Chan, MD (PRINCIPAL_INVESTIGATOR)
Rami Komrokji, MD (SUB_INVESTIGATOR)
Timothy Kubal, MD (SUB_INVESTIGATOR)
Andrew Kuykendall, MD (SUB_INVESTIGATOR)
Jeffrey Lancet, MD (SUB_INVESTIGATOR)
Eric Padron, MD (SUB_INVESTIGATOR)
David Sallman, MD (SUB_INVESTIGATOR)
Alison Walker, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Moffitt Cancer Center· Tampa, FL

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