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DNA Methylation Inhibitor

Combination Therapies for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Mary L Savoie
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
Age 18-59 years at time of induction therapy
Eastern Cooperative Oncology Group (ECOG) performance status <= 3
Must not have
Prior therapy for AML except for hydroxyurea and leukapheresis
Patients with isolated myeloid sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial is testing different drug combinations to treat younger patients with a type of blood cancer called acute myeloid leukemia (AML). They are comparing the effectiveness of using cytarabine and daun

Who is the study for?
This trial is for younger patients with intermediate risk acute myeloid leukemia (AML) who have specific genetic mutations or changes. They must be enrolled in the MyeloMATCH program, assigned to this study based on actionable mutations, and agree to submit specimens for research.
What is being tested?
The trial compares three treatments: Cytarabine + Daunorubicin; Cytarabine + Daunorubicin + Venetoclax; and Venetoclax + Azacitidine. It aims to see if adding Venetoclax improves treatment effectiveness by at least 20% over standard therapy.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased infection risk due to low blood cell counts, and possible organ damage. Specific side effects of each drug may vary.

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 am capable of limited self-care and spend more than half of my waking hours out of bed.
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My hepatitis B virus load is undetectable.
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I have a new diagnosis of acute myeloid leukemia with more than 20% myeloblasts.
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My heart pumps blood effectively.
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My kidney function, measured by creatinine clearance, is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have AML and have only been treated with hydroxyurea or leukapheresis.
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I have a condition known as isolated myeloid sarcoma.
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I am allergic to certain chemotherapy drugs like cytarabine or daunorubicin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Residual Tumor
Secondary study objectives
Complete remission (CR) rates
Complete remission with incomplete count recovery (CRi)
Event-free survival (EFS)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ARM II (azacitidine, venetoclax)Experimental Treatment4 Interventions
Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Group II: ARM I (daunorubicin, cytarabine, venetoclax)Experimental Treatment5 Interventions
Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment, patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Group III: ARM III (daunorubicin, cytarabine)Active Control4 Interventions
Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment, patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Azacitidine
2012
Completed Phase 3
~1440
Biospecimen Collection
2004
Completed Phase 3
~2020
Venetoclax
2019
Completed Phase 3
~2200
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,847 Total Patients Enrolled
Mary L SavoiePrincipal InvestigatorCanadian Cancer Trials Group
~102 spots leftby Dec 2025
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