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Anti-metabolites

Chemotherapy for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Joseph M Scandura

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

Diagnosis of acute myeloid leukemia (AML) as defined by the World Health Organization

Molecular AML-risk group is less-than-favorable as defined by specific criteria

Must not have

Cumulative lifetime dose of anthracycline chemotherapeutic > 80 mg/m^2

Uncontrolled intercurrent illness considered high risk for treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from entry on study until documentation of cr, up to second course of induction chemotherapy

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing two doses of decitabine given with daunorubicin hydrochloride and cytarabine to see how well it works in treating patients with acute myeloid leukemia.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) who don't have favorable-risk genetic mutations and are in good physical condition. They must not be pregnant, agree to use birth control, and cannot have had certain treatments recently or a high lifetime dose of similar chemotherapy drugs. People with uncontrolled illnesses, HIV with low CD4 counts, or serious heart conditions can't join.

What is being tested?

The study tests how well decitabine works alongside daunorubicin hydrochloride and cytarabine in AML treatment. It compares the effectiveness of low-dose versus high-dose decitabine when combined with these chemotherapy drugs to see if it makes cancer cells more sensitive to treatment.

What are the potential side effects?

Potential side effects include reactions related to the immune system, blood cell counts changes leading to increased infection risk or bleeding problems, nausea, vomiting, liver function alterations, fatigue and potential heart complications due to the nature of chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with acute myeloid leukemia.

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My AML is classified as high-risk based on its genetics.

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I do not have a specific type of leukemia known as APL.

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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 heart is functioning well, as confirmed by a heart scan.

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My kidney function is normal or only slightly impaired.

Exclusion Criteria

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

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I have received more than 80 mg/m^2 of anthracycline chemotherapy in my lifetime.

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I have a serious illness that makes treatment risky for me.

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I am HIV-positive with a CD4 count below 200.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from entry on study until documentation of cr, up to second course of induction chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from entry on study until documentation of cr, up to second course of induction chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from entry on study until documentation of cr, up to second course of induction chemotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Time to complete response determined according to the International Working Group (IWG) criterion

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

All Individual Drugs Already Approved

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (decitabine, daunorubicin hydrochloride, cytarabine)Experimental Treatment5 Interventions

Patients receive decitabine IV over 1 hour on days -5 to -1. Patients then receive induction chemotherapy as in arm I in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.

Group II: Arm I (daunorubicin hydrochloride, cytarabine)Experimental Treatment4 Interventions

Patients receive induction chemotherapy comprising daunorubicin hydrochloride IV daily on days 1-3 and cytarabine IV continuously on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Decitabine

FDA approved

Daunorubicin

FDA approved

0 / 9Eligibility criteria met