← Back to Search

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

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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

Select...

I can care for myself but may need occasional help.

Select...

I am 60 years old or older.

Exclusion Criteria

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

Select...

I have serious kidney or liver problems that could make chemotherapy unsafe for me.

Select...

My AML cancer has returned or didn't respond to treatment and needs more therapy.

Select...

I need urgent chemotherapy for my leukemia due to severe complications.

Select...

I do not have any serious infections that are not under control.

Select...

I have previously been treated with decitabine or azacitidine.

Select...

My heart's pumping ability is below 45%.

Select...

I have been diagnosed with acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Mortality

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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