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DNA Methyltransferase Inhibitor

Quizartinib + Decitabine + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Musa Yilmaz

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

Chemonaive patients for frontline cohort

Various health and medical criteria including performance status, biochemical values, white blood cell count, electrolyte levels, ability to take oral medication, ability to understand and provide signed informed consent, cardiac function, pregnancy test, contraception, and use of investigational agents

Must not have

Prior quizartinib use

Other severe and/or uncontrolled medical conditions or concurrent malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

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

Who is the study for?

This trial is for adults with untreated or relapsed Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS). Eligible participants include those over 60 not fit for intensive therapy, under 60 with poor risk factors, and must have specific genetic mutations. They should be able to take oral medication and not have severe medical conditions or allergies related to the drugs tested.

What is being tested?

The study tests a combination of quizartinib, decitabine, and venetoclax in patients with AML/MDS. Quizartinib targets enzymes that cancer cells need to grow while decitabine and venetoclax are chemotherapy drugs aimed at stopping cancer cell growth by various mechanisms.

What are the potential side effects?

Potential side effects may include allergic reactions to the medications used, heart-related issues such as abnormal heart rhythms, gastrointestinal disturbances which could affect drug absorption, blood disorders from chemotherapy agents, fatigue due to treatment regimen.

Eligibility Criteria

Inclusion Criteria

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

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I have not received chemotherapy for my condition.

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I am generally healthy, can take pills, understand and agree to the study, not pregnant, and not on experimental drugs.

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

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I am 18 or older and not eligible for or refuse curative treatments like stem cell transplantation.

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I have had at least one treatment for AML or MDS with more than 10% blasts.

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I have been diagnosed with AML, not including APL, or MDS with more than 10% blasts.

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I am 60 or older and agree to the proposed therapy because intensive treatment isn't suitable for me.

Exclusion Criteria

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

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I have previously used quizartinib.

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I do not have other severe illnesses or cancers.

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I have a serious digestive system condition.

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I have had a major surgery recently.

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I have leukemia that has spread to my brain and is not under control.

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I am taking a strong medication that affects liver enzyme levels.

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I am not taking certain drugs that could interfere with the study.

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I am HIV positive.

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My family has a history of long QT syndrome.

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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, quizartinib, venetoclax)Experimental Treatment3 Interventions

Patients receive decitabine IV over 1 hour on days 1-10, quizartinib PO every day beginning on day 1 of cycle 1, and venetoclax PO on days 1-14 (days 1-21 if persistent leukemia). 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

Decitabine

FDA approved

Venetoclax

FDA approved

Quizartinib

Not yet FDA approved

0 / 16Eligibility criteria met