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Anti-metabolites

Discontinuing Decitabine/Azacitidine + Venetoclax for AML

Phase 2
Recruiting
Led By Onyee Chan, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
Eastern Cooperative Group (ECOG) performance status score ≤ 2
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Summary

This trial is trying to find out if patients with Acute myeloid leukemia (AML) who are responding well to treatment with azacitidine or decitabine along with venetocl

Who is the study for?
This trial is for individuals with Acute Myeloid Leukemia (AML) who are responding well to treatment with azacitidine or decitabine plus venetoclax. They must have completed at least a year of this therapy without their AML returning.
What is being tested?
The study investigates whether patients can safely stop taking the chemotherapy drugs azacitidine or decitabine in combination with venetoclax after one year of successful treatment, without increasing the risk of AML recurrence.
What are the potential side effects?
Potential side effects from azacitidine, decitabine, and venetoclax include nausea, vomiting, diarrhea, fatigue, low blood counts leading to increased infection risk and bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not eligible for or have declined a stem cell transplant from a donor.
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I can do most of my daily activities by myself.
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I am 18 years old or older.
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I have been diagnosed with a specific type of leukemia (AML, non-M3).
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I am in complete remission from my cancer after initial treatment and have no minimal residual disease.
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I can provide bone marrow samples for testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer was diagnosed with a TP53 mutation.
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My AML affects areas outside the bone marrow, like the brain, skin, or forming a solid tumor.
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I don't have any serious illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi)
Secondary study objectives
EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30)/Quality of Life (QoL)
Overall Survival (OS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Consolidation and DiscontinuationExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200
Azacitidine
2012
Completed Phase 3
~1440
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
1,004 Previous Clinical Trials
513,741 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,503 Total Patients Enrolled
Onyee Chan, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
40 Total Patients Enrolled
~25 spots leftby Jun 2028
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