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DNA Methyltransferase Inhibitor

Personalized Therapy for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Vijaya R Bhatt, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status of 60% or higher
Patients aged 60 years or older
Must not have
Clinically significant kidney dysfunction (e.g. GFR ≤45ml/minute or Creatinine of ≥2 mg/dl) or liver dysfunction (e.g. AST/ALT and/or bilirubin ≥2 times ULN) at the time of enrollment that may prevent safe use of chemotherapy
Patients with relapsed or refractory AML, who require salvage therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Summary

This trial will study the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older patients.

Who is the study for?
This trial is for people aged 60 or older with a new diagnosis of acute myeloid leukemia (AML) who can consent to treatment. They must be relatively active and healthy enough for chemotherapy, without severe heart, kidney, or liver issues that would make the treatment unsafe.
What is being tested?
The study tests different AML treatments based on genetic risk and health status in older adults. It aims to see how well patients respond to therapy tailored by their clinicogenetic profile over a period of two years.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as fatigue, nausea, increased infection risk due to low blood cell counts, hair loss, and potential organ damage which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious kidney or liver problems that could make chemotherapy unsafe for me.
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My AML cancer has returned or didn't respond to treatment and needs more therapy.
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I need urgent chemotherapy for my leukemia due to severe complications.
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I do not have any serious infections that are not under control.
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I have previously been treated with decitabine or azacitidine.
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My heart's pumping ability is below 45%.
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I have been diagnosed with acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Rate of complete remission and mortality in the entire cohort of older patients
Secondary study objectives
Baseline functional status
Baseline functional status measure by geriatric assessment
Functional status
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group IIExperimental Treatment7 Interventions
LOW-INTENSITY: Patients receive venetoclax in combination with azacitidine or decitabine or other standard of care low-intensity therapy such as azacitidine or decitabine alone or in combination with FLT3 inhibitor such as midostaurin, low-dose cytarabine in combination with glasdegib. Venetoclax dose varies depending on drug interaction with antifungal agents. Given daily continuous for \>= 3 months orally. Glasdegib dose is 100 mg oral daily. Decitabine IV over 1-3 hours daily for 5-10 days. Treatment repeats every 4-5 weeks for \>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant. Azacitidine IV infusion over 10 to 40 minutes days 1 -7. Treatment repeats every 4-5 weeks for \>= 3 courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.
Group II: Group IExperimental Treatment6 Interventions
INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of unacceptable toxicity. INTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression, unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Idarubicin
FDA approved
Daunorubicin
FDA approved
Venetoclax
FDA approved
Glasdegib
FDA approved
Decitabine
FDA approved
Azacitidine
FDA approved

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
554 Previous Clinical Trials
1,145,361 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,925 Total Patients Enrolled
Vijaya R Bhatt, MDPrincipal InvestigatorUniversity of Nebraska

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03226418 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Group I, Group II
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT03226418 — Phase 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03226418 — Phase 2
~0 spots leftby Oct 2024
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