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Anti-metabolites

Chemotherapy + Midostaurin for Acute Myeloid Leukemia

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unequivocal diagnosis of AML (> 20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia)

Age ≥ 18 and < 60 years

Must not have

History of therapy-related AML after prior RT or chemotherapy for another cancer or disorder

Women of childbearing potential not using two acceptable methods of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of study (up to 10 years)

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Summary

This trial is testing whether adding midostaurin to standard chemotherapy improves treatment outcomes in patients with FLT3-positive acute myeloid leukemia.

Who is the study for?

This trial is for adults aged 18-60 with newly diagnosed Acute Myeloid Leukemia (AML) who have a specific FLT3 gene mutation. They must not have had previous leukemia or myelodysplasia treatments, except under certain conditions like emergency leukapheresis. Pregnant or nursing women can't join, and participants must agree to use effective birth control methods.

What is being tested?

The study compares standard AML chemotherapy (daunorubicin and cytarabine) with the addition of midostaurin versus without it. Midostaurin targets an enzyme linked to AML cell growth in patients with the abnormal FLT3 gene. The goal is to determine if adding midostaurin improves treatment outcomes.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts, and organ damage. Midostaurin may also cause gastrointestinal symptoms, skin problems, or allergic reactions.

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 AML, not including type M3.

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I am between 18 and 59 years old.

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My leukemia has a FLT3 mutation.

Exclusion Criteria

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

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I developed AML as a result of treatment for another cancer.

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I am a woman who can have children and am not using two forms of birth control.

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I have symptoms of heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of study (up to 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of study (up to 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (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

Overall Survival (OS)

Secondary study objectives

Complete Response Rate

Disease-free Survival (DFS)

Event- Free Survival

+1 more

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Induction and consolidation chemotherapy plus midostaurinExperimental Treatment4 Interventions

Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug midostaurin. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with the experimental drug midostaurin. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with midostaurin for twelve (12) months.

Group II: Induction and consolidation chemotherapy plus placeboActive Control4 Interventions

Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and placebo. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with placebo. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with placebo for twelve (12) months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Dexamethasone acetate

FDA approved

Midostaurin

FDA approved

Daunorubicin

FDA approved