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DNA Methyltransferase Inhibitor

Venetoclax + Decitabine for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Marina Konopleva

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old

Adequate renal function including creatinine < 2 unless related to the disease

Must not have

Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)

Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying venetoclax and decitabine to see how well they work in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.

Who is the study for?

This trial is for adults under 60 with newly diagnosed AML or high-risk MDS, not responding to treatment or relapsed. Participants must have adequate liver and kidney function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have certain blood cancers (like acute promyelocytic leukemia) or uncontrolled medical conditions.

What is being tested?

The study tests how well venetoclax combined with decitabine works in treating relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). It's a phase II trial focusing on the effectiveness of these chemotherapy drugs in stopping cancer cell growth.

What are the potential side effects?

Venetoclax and decitabine can cause side effects like low blood cell counts leading to increased infection risk, bleeding problems, fatigue, nausea, vomiting, diarrhea. Liver function may also be affected. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 or younger with a specific type of aggressive AML.

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My kidney function is normal, with creatinine levels below 2.

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I have high-risk MDS or CMML, failed or relapsed after HMA therapy.

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I am over 60 and have a certain type of leukemia but can't undergo strong chemotherapy.

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I am capable of limited self-care and spend less than half of my day in bed or sitting.

Exclusion Criteria

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

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My leukemia is of a specific type known as APL (M3-AML).

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I have leukemia in my brain that is causing symptoms or is not well-controlled.

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I do not have any severe ongoing health issues like uncontrolled infections, high blood pressure, heart failure, or irregular heartbeats.

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I have previously received BCL2 inhibitor therapy.

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I have an active HIV, hepatitis B, or hepatitis C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Overall response rate (ORR)

Secondary study objectives

Disease free survival

Duration of response

Incidence of adverse events

+1 more

Other study objectives

Biomarker analysis

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 (decitabine, venetoclax)Experimental Treatment3 Interventions

Participants receive decitabine IV over 1 hour on days 1-10 and may also receive decitabine on days 1-5 after achieving complete remission/complete remission with incomplete count recovery during consolidation/maintenance. Participants also receive venetoclax PO daily on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles. Treatment repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

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