Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
CPKC412E2301
Clinical summary
Summary
This study aims to assess the benefits of using a combination of Midostaurin and chemotherapy to treat Acute Myeloid Leukaemia - FLT3 Mutation Negative. Patients eligible to participate in this study will initially receive midostaurin, or a placebo, twice a day as well as chemotherapy. This will be followed by 12 x 28-day cycles of midostaurin, or placebo, alone.
Conditions
This trial is treating people with Acute Myeloid Leukaemia
Eligibility
Inclusion
- Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL with PML-RARA are not eligible.
- Suitability for intensive induction chemotherapy in the judgment of the investigator
- Documented absence of an ITD and TKD activating mutation at codons D835 and I836 in the FLT3 gene, as determined by analysis in a Novartis designated laboratory using a validated clinical trial assay with clinical cutoff of 0.05 mutant to wild type signal ratio
- Age ≥18 years
- Laboratory values that indicate adequate organ function assessed locally at the screening visit
Exclusion
- Central nervous system (CNS) leukemia
- Therapy-related secondary AML
- Isolated extramedullary leukemia
- Prior therapy for leukemia or myelodysplasia
- AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
- Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific Title
A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)
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