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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (Phase II)

Maximum tolerated dose of the combination drugs (Phase I)

Overall response rate (ORR) including CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) + partial remission (PR) (Phase II)

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,060 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,248 Total Patients Enrolled

Musa YilmazPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

132 Total Patients Enrolled

Media Library

Decitabine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03661307 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Treatment (decitabine, quizartinib, venetoclax)

Myelodysplastic Syndrome Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03661307 — Phase 1 & 2

Decitabine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03661307 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the main reasons why Venetoclax is given to patients?

"While most often used to treat refractory anemia, Venetoclax can also be given as a treatment for other conditions such as ipss risk category intermediate-1, chronic lymphocytic leukemia (cll), and ipss risk category intermediate-2."

Answered by AI

How many total patients will be included in this research project?

"That is correct. The clinical trial in question, which was first advertised on October 31st 2018, appears to be actively recruiting patients according to the information available on clinicaltrials.gov. They are looking for 52 individuals across 1 location."

Answered by AI

Are new patients being sought for this clinical trial?

"Yes, this information is accurate. The trial was first posted on October 31st, 2018 and was updated as recently as October 10th, 2020."

Answered by AI

What is the history of Venetoclax in research?

"As of now, 44 out of 319 total clinical trials testing Venetoclax are in Phase 3. Most of these studies originate in Edmonton, Alberta; however, there are 9007 other locations around the world where Venetoclax is being trialled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

2018. "Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03661307.