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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine for Leukemia

Phase 2

Recruiting

Led By Daniel Pollyea, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2

Without clinical signs of active central nervous system disease

Must not have

Subject has a malabsorption syndrome or other condition that precludes enteral route of administration

Subject exhibits evidence of uncontrolled systemic infection requiring therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study start date to study end date, or death, whichever comes first, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new treatment for people with leukemia who have not responded to other treatments.

Who is the study for?

Adults aged 18-59 with newly diagnosed acute myeloid leukemia (AML) who haven't been treated before can join. They should be in relatively good health, with an ECOG score of ≤2, and have normal liver and kidney function. Men must use contraception; women not post-menopausal or without a hysterectomy/oophorectomy must use two forms of birth control or abstain from sex.

What is being tested?

The trial is testing the combination of two drugs, Venetoclax and Azacitidine, as a treatment for AML in non-elderly adults. It's aimed at those who are newly diagnosed and have not received any prior treatments for their condition.

What are the potential side effects?

Possible side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, liver issues, kidney problems and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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

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I do not have symptoms of brain or spinal cord disease.

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My leukemia is confirmed as non-APL and AML according to WHO standards.

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I am between 18 and 59 years old.

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My liver functions are within normal limits, unless affected by leukemia.

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My leukemia is considered high-risk according to European standards.

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

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I have not received any treatment for AML.

Exclusion Criteria

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

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I cannot take medicine by mouth due to a digestive condition.

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I am currently being treated for a serious infection that is not under control.

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I am HIV positive.

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I am willing to undergo strong initial chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study start date to study end date, or death, whichever comes first, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study start date to study end date, or death, whichever comes first, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, or death, whichever comes first, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate, measured by the European Leukemia Net definition: (CRMRD-+CR+CRi+MLFS)

Secondary study objectives

Incidence of Minimal Residual Disease (MRD) Negative Responses

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

One Year Event Free Survival

+2 more

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: Azacitidine and VenetoclaxExperimental Treatment2 Interventions

Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished.

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