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Demethylation agents

Novel Therapies for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Paul J Shami
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 18 and 59 years of age
Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial compares different treatment regimens for high-risk acute myeloid leukemia (AML) to see which one works best in shrinking cancer cells. The standard treatment is cytarabine and daun

Who is the study for?
This trial is for adults aged 18-59 with newly diagnosed, untreated high-risk acute myeloid leukemia (AML) as defined by specific criteria. Eligible participants must not have had previous AML treatment, except hydroxyurea or a single dose of intrathecal chemotherapy. Prior limited anthracycline therapy and exposure to hypomethylating agents for non-AML conditions are permitted.
What is being tested?
The study compares standard cytarabine and daunorubicin treatments against four experimental regimens: liposome-encapsulated versions alone; combined with venetoclax; azacitidine with venetoclax; and the combination of all three drugs. These new approaches may be more effective in treating high-risk AML.
What are the potential side effects?
Potential side effects include heart problems due to daunorubicin, bone marrow suppression leading to increased infection risk from cytarabine, gastrointestinal issues from venetoclax, and possible liver toxicity from azacitidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 59 years old.
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I can swallow pills and don't have stomach issues affecting medication absorption.
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I can care for myself but cannot do any physical work.
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I have chronic hepatitis B but my viral load is undetectable and I'm on treatment if needed.
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I have HIV, am on effective treatment, and my viral load has been undetectable for the last 6 months.
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I have been newly diagnosed with AML according to WHO standards.
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My AML developed from previous cancer treatment or another blood disorder.
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My leukemia is not the acute promyelocytic type.
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My condition is considered high-risk.
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My cancer does not have FLT3 mutations.
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I do not have the t(9;22) genetic abnormality.
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My AML is classified as high-risk according to ELN 2017.
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My heart is strong, with an ejection fraction of 50% or higher.
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I do not have Wilson's disease or any copper-metabolism disorder.
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I had hepatitis C but have been successfully treated and cured.
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My kidneys work well, with a creatinine clearance of at least 30 mL/min.
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I have not had treatment for acute myeloid leukemia.

Timeline

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minimal residual disease (MRD) response (Arm 1, 2, 4 and 5)
Minimal residual disease (MRD) response (Arm 3)
Secondary outcome measures
Early mortality
Event-free survival (EFS)
Incidence of adverse events
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm V (daunorubicin and cytarabine liposome, venetoclax)Experimental Treatment6 Interventions
Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group II: Arm IV (daunorubicin and cytarabine liposome)Experimental Treatment5 Interventions
Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group III: Arm III (azacitidine, venetoclax)Experimental Treatment5 Interventions
Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group IV: Arm II (cytarabine, daunorubicin, venetoclax)Experimental Treatment7 Interventions
Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Group V: Arm I (cytarabine, daunorubicin)Active Control6 Interventions
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330
Echocardiography
2013
Completed Phase 4
~11580
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~2200
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,665 Total Patients Enrolled
Paul J ShamiPrincipal InvestigatorSWOG Cancer Research Network
~223 spots leftby Mar 2027
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