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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (up to 10 years)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Complete Response Rate
DFS Rate One Year After Completing the Planned Continuation Phase
Disease-free Survival (DFS)
+2 more

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

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,917 Total Patients Enrolled
46 Trials studying Leukemia
32,856 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,912,770 Total Patients Enrolled
1,508 Trials studying Leukemia
378,659 Patients Enrolled for Leukemia
Novartis PharmaceuticalsIndustry Sponsor
2,851 Previous Clinical Trials
4,196,924 Total Patients Enrolled
151 Trials studying Leukemia
23,210 Patients Enrolled for Leukemia

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00651261 — Phase 3
Leukemia Research Study Groups: Induction and consolidation chemotherapy plus midostaurin, Induction and consolidation chemotherapy plus placebo
Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT00651261 — Phase 3
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00651261 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential side effects of cytarabine for patients?

"Cytarabine has received a safety score of 3 from our team at Power. This is because, as a Phase 3 trial, there is both some evidence of its efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

Might this research be appropriate for patients who are no longer considered young adults?

"The age requirements for participants in this trial are between 18 and 59 years old."

Answered by AI

Are there any prerequisites that participants must meet before enrolling in this research project?

"The ideal candidate for this leukemia trial is between 18-59 years old. Out of the 717 people that the researchers are looking for, how many might you be able to help them find?"

Answered by AI

How is cytarabine administered and what are its benefits?

"cytarabine is most often used as treatment for leukemia, myelocytic, acute. However, it has also been used to effectively treat conditions such as blast phase chronic myelocytic leukemia, fungal vaginal infections, lymphoma."

Answered by AI

Do we have a history of using cytarabine in previous medical trials?

"As of now, 285 studies concerning cytarabine are active with 69 of those in the third stage of testing. Although a large concentration of these studies take place in Providence, Rhode island, there are 12,819 locations running cytarabine trials in total."

Answered by AI
Recent research and studies
~42 spots leftby Mar 2025