Chemotherapy + Midostaurin for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+175 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.

Research Team

Richard M. Stone, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I haven't had chemotherapy for leukemia or myelodysplasia, except in emergencies.

I have been diagnosed with AML, not including type M3.

I am between 18 and 59 years old.

Exclusion Criteria

Positive serum or urine pregnancy test within 16 days prior to registration

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

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

Treatment Details

Interventions

• Cytarabine (Anti-metabolites)
• Daunorubicin (Anti-tumor antibiotic)
• Midostaurin (Protein Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Induction and consolidation chemotherapy plus midostaurin Experimental Treatment 4 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 placebo Active Control 4 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.

Cytarabine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cytosar-U for:

• Acute myeloid leukemia
• Acute lymphocytic leukemia
• Chronic myeloid leukemia
• Meningeal leukemia

🇪🇺 Approved in European Union as Depocyt for:

• Lymphomatous meningitis

🇨🇦 Approved in Canada as Cytosar-U for:

• Acute myeloid leukemia
• Acute lymphocytic leukemia
• Chronic myeloid leukemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CCOP - North Shore University Hospital Manhasset, NY

Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, FL

CCOP - Grand Rapids Grand Rapids, MI

Regions Hospital Cancer Care Center Saint Paul, MN

More Trial Locations

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Patients Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2963

Patients Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

References