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Anti-metabolites

Azacitidine/Decitabine + Venetoclax for Acute Myeloid Leukemia

Clovis, CA

Phase 2

Recruiting

Led By Brian A Jonas

Research Sponsored by Brian Jonas

Eligibility Criteria Checklist

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

Must have

Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)

Treatment naïve and eligible for venetoclax plus HMA

Must not have

Diagnosis of acute promyelocytic leukemia

Known diagnosis of HIV infection or known active hepatitis A, B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before or has come back.

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Who is the study for?

Adults diagnosed with acute myeloid leukemia (AML) who have not been treated for AML before or whose AML has returned. They must have previously failed treatment with hypomethylating agents for a related blood disorder and be able to take oral medication. Women of childbearing age must test negative for pregnancy and agree to use contraception, as should men with partners of childbearing potential.Check my eligibility

What is being tested?

The trial is testing the combination of chemotherapy drugs azacitidine or decitabine with venetoclax in patients with AML that's either new or has come back after previous treatments. The goal is to see how well these drugs work together in stopping cancer cell growth by killing them, halting division, or preventing spread.See study design

What are the potential side effects?

Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk and bleeding problems, fatigue, liver issues indicated by abnormal tests results, kidney function changes requiring monitoring and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is AML, confirmed by the latest WHO criteria.

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I have not received any treatment and am eligible for venetoclax plus HMA therapy.

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My previous treatment with HMA for a blood disorder did not work.

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I can swallow and keep down pills.

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I have been treated with decitabine or azacitidine for a blood disorder before.

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I am 18 years old or older.

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I can take care of myself but might not be able to do active work.

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Exclusion Criteria

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

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I have been diagnosed with acute promyelocytic leukemia.

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I have been diagnosed with HIV or active hepatitis A, B, or C.

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My acute myeloid leukemia has spread to my brain or spinal cord.

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I am currently being treated for a serious infection.

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

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My heart condition limits my physical activity significantly.

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I have had cancer before, but it was treated with the goal of curing it.

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I have been treated with venetoclax before.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate

Secondary study objectives

Duration of CR/CRi (DoR)

Event-free survival

Incidence of adverse events

+5 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: Treatment (azacitidine, decitabine, venetoclax)Experimental Treatment3 Interventions

Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 (for patients with prior decitabine use), or decitabine IV on days 1-5 (for patients with prior azacitidine), and venetoclax PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2290

Azacitidine

2014

Completed Phase 3

~1470