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DNA Methyltransferase Inhibitor

Venetoclax + ASTX727 for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Farhad Ravandi-Kashani
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
Either age >= 75 years
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study Summary

This trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia.

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) that's resistant to treatment, has returned after treatment, or newly diagnosed in elderly patients unfit for intensive chemotherapy. Participants must be over 18, have a performance status indicating they can care for themselves with varying degrees of assistance, and meet specific health criteria related to liver and kidney function.Check my eligibility
What is being tested?
The trial is testing the combination of Venetoclax and ASTX727 (a fixed-dose combo of cedazuridine and decitabine) on AML. Venetoclax aims to prevent cancer growths while ASTX727 may slow down cell growth by making decitabine last longer in the body before it breaks down.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems. Liver function abnormalities are also possible along with other symptoms like fever or cough if infections occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 75 years old or older.
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I agree to use birth control during and for 3 months after the study ends.
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I can take care of myself but might not be able to do heavy physical work.
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My liver function is moderately impaired.
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I am not eligible for initial standard cancer treatment.
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My AML has not responded to or has come back after previous treatment.
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My kidneys work well enough, with a creatinine clearance of 45 ml/min or more.
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I am not able to have children, am postmenopausal, or have a negative pregnancy test.
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I can take hydroxyurea for my fast-growing disease before and during the first cycle of the study, if needed.
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I am 18 years old or older.
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I am 18-74 years old with a serious health condition like heart failure or lung problems.
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I have been recently diagnosed with acute myeloid leukemia (AML).
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My kidney function is low but not critically so.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall incidence and severity of all adverse events
Overall response rate (ORR)
Secondary outcome measures
Disease free survival
Overall survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine and cedazuridine, venetoclax)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO daily on days 1-5 and venetoclax PO daily on days 1-28 of the first cycle and on days 1-21 of subsequent cycles. Treatment repeats 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
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
666 Total Patients Enrolled

Media Library

Decitabine and Cedazuridine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04746235 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (decitabine and cedazuridine, venetoclax)
Acute Myeloid Leukemia Clinical Trial 2023: Decitabine and Cedazuridine Highlights & Side Effects. Trial Name: NCT04746235 — Phase 2
Decitabine and Cedazuridine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04746235 — Phase 2

Frequently Asked Questions

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

Could you explain the hazards associated with Decitabine and Cedazuridine for those undergoing treatment?

"Our team at Power assigned Decitabine and Cedazuridine a score of 2 in terms of safety, since it is only approved for Phase 2 trials which indicates some evidence of safety but no confirmation on efficacy."

Answered by AI

What have been the outcomes of previous tests concerning Decitabine and Cedazuridine?

"Currently, 303 trials are running with Decitabine and Cedazuridine as the primary focus. Of those, 43 have entered Phase 3. While Edmonton, Alberta is home to most of these studies, there are 8631 sites all over the world offering this treatment option."

Answered by AI

What is the current enrollment for this research endeavor?

"Affirmative. By checking clinicaltrials.gov, we can ascertain that this medical trial is enlisting new patients and was first submitted on February 22nd 2021. At the moment, 40 participants are required from a single site before December 7th 2022."

Answered by AI

Is there space available for volunteers to participate in this trial?

"Current information on clinicaltrials.gov affirms that this research project is actively recruiting individuals for participation. The trial was first announced in February 2021 and the most recent update to its data occurred in December 2022."

Answered by AI

For what conditions are Decitabine and Cedazuridine typically utilized?

"Decitabine and Cedazuridine are both effective therapies for refractory anemia, intermediate-1 International Prognostic Scoring System (IPSS) risk category, and chronic lymphocytic leukemia."

Answered by AI
~6 spots leftby Oct 2024