Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chem… (NCT03379727) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who were eligible for standard induction and consolidation
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent must be obtained prior to any screening procedures.
. Patients must be 18 years of age or older at the time of signing informed consent.
. Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification. A bone marrow or blood blast count of ≥ 20% is required, except for AML with t(15;17), t(8;21), inv(16) or t(16;16) where blast count may be \<20%, and, excluding M3 (acute promyelocytic leukemia).
. Patients with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
. Patients must have started "7+3" or "5+2" first induction chemotherapy regimen.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial combined midostaurin with standard chemotherapy and then continued midostaurin alone for 12 months of maintenance, can you walk me through what that full treatment timeline would actually look like for me and whether my schedule and support system could realistically handle it?
2This was a Phase 3 trial focused primarily on measuring safety outcomes like serious adverse events and discontinuations over two years — what does the safety data collected so far tell us about the risks of adding midostaurin to standard chemotherapy, and how does that weigh against going with standard chemotherapy alone?
3My leukemia would need to be confirmed as FLT3-mutated to even be considered for this approach — has my tumor already been tested for FLT3 mutations, and if not, how soon can that testing be done?
4Since the trial has already completed recruitment, the results may be available or emerging — have you seen any published findings from this study that could help us understand how well midostaurin worked in newly diagnosed FLT3-mutated AML patients like me?
5Given that this trial is now closed to new participants, is there a currently open study or an approved standard-of-care regimen using midostaurin for FLT3-mutated AML that might be a more accessible path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24).
. Patients must have a documented FLT3 mutation (ITD or TKD).).
. Patients must have an ECOG Performance Status of ≤ 2
. Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
Exclusion criteria
. Prior therapy for AML with the following exceptions:
. emergency leukapheresis
. emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 7 days
. cranial RT for CNS leukostasis (one dose only)
. growth factor/cytokine support
. Patients with LVEF less than 45% (by echocardiogram or MUGA) or symptomatic congestive heart failure (Class III or IV) according to New York Heart Association (NYHA) classification
. Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolved to ≤ Grade 1 within screening timeframe)
. Patients with any uncontrolled illness, including, but not limited to, acute or chronic pancreatitis or uncontrolled infection