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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Decitabine

2011

Completed Phase 3

~2370

Azacitidine

2012

Completed Phase 3

~1440