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#Midostaurin free clinical trials trial
The data, collected and analyzed in partnership with the Alliance for Clinical Trials in Oncology, are from the largest clinical trial in FLT3-mutated AML to date, with 3,279 patients screened and 717 study participants from around the world4. The trial evaluated the addition of either PKC412 (midostaurin) or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 (midostaurin) or placebo as a single agent for up to one year4. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval : 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group4.
#Midostaurin free clinical trials plus
In the study, adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy experienced a 23% improvement in overall survival (OS) (hazard ratio = 0.77, P = 0.0074) compared to those treated with standard induction and consolidation chemotherapy alone4.
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6, 2015 /PRNewswire/ - Novartis today announced positive results from the global Phase III RATIFY (CALGB 10603) clinical trial. Currently there are no approved targeted AML treatments worldwide regulatory submissions for PKC412 (midostaurin) to begin in 2016ĭec 06, 2015, 11:15 ET from Novartis Pharmaceuticals Corporation ()ĮAST HANOVER, N.J., Dec.
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AML is the most common acute leukemia in adults, but has the lowest survival rate no change in treatment strategy in more than 25 years.Study in partnership with the Alliance for Clinical Trials in Oncology is the first large controlled trial to show overall survival benefit in FLT3-mutated AML.