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DNA Methyltransferase Inhibitor

Venetoclax + Decitabine for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Olatoyosi Odenike, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk AML, including any of the following: Relapsed or refractory disease; TP53 mutant AML; Adverse risk cytogenetics including any of the following: 3 or more abnormalities; deletions involving chromosomes 5, 7, or 17; abnormalities in chromosome 11 involving MLL; t(6;9); inv(3) or t(3;3); ECOG performance status 0-2; Age 18 years or older

During the Phase 2 portion of the study, the subject population will be limited to patients with previously untreated AML with a mutation in TP53. All other inclusion criteria described above will apply.

Must not have

- Known CNS involvement with AML

- Moderate or strong cytochrome P450 3A (CYP3A) inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an experimental drug to see if it is safe and effective when given to people with a specific type of leukemia.

Who is the study for?

Adults with acute myeloid leukemia (AML) can join this trial. Phase 1 is for those with high-risk AML, including relapsed or refractory disease and specific genetic changes. They must have good organ function and not be on certain treatments recently. Phase 2 is specifically for untreated AML patients with TP53 mutations. Pregnant women, HIV-positive individuals, and those with other significant health issues cannot participate.

What is being tested?

The study tests the safety of Venetoclax combined with Decitabine in treating AML. Participants will receive both drugs to see how well they tolerate them and what effects they have on their leukemia.

What are the potential side effects?

Venetoclax may cause side effects like low blood cell counts leading to increased infection risk, bleeding or bruising; fatigue; nausea; diarrhea; pneumonia among others. Decitabine's side effects include anemia, neutropenia (low white blood cell count), thrombocytopenia (low platelets), fever, cough, and shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have AML with a TP53 mutation and haven't been treated for it yet.

Select...

My AML is considered high risk.

Select...

My condition has returned or didn't respond to treatment.

Select...

My leukemia is TP53 mutant.

Select...

I am 18 years old or older.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

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My kidneys are functioning well enough, as shown by tests.

Select...

My cancer has specific genetic features considered high-risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My leukemia has spread to my brain or spinal cord.

Select...

I am not taking any strong medications that affect liver enzymes.

Select...

I have been diagnosed with acute promyelocytic leukemia.

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I am on steroids for cancer treatment.

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I have previously been treated with venetoclax, decitabine, or azacitidine.

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I have a history of heart failure or my heart pumps less effectively.

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I have heart disease that causes symptoms like fatigue or chest pain with normal activity.

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I am not receiving any cancer treatments not listed in this study's protocol.

Select...

I do not have an active or uncontrolled infection.

Select...

My heart condition limits my physical activity significantly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

The rate of dose limiting toxicity (DLT)

Secondary study objectives

Assessment of Overall Survival

Levels of toxicity with combination regimen

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

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: TreatmentExperimental Treatment2 Interventions

Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1720

Venetoclax

2019

Completed Phase 3

~2240