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CompletedLast updated: 7 February 2024

CPKC412E2301: This phase III trial is assessing the effectiveness and safety of administering a targeted therapy (Midostaurin) in combination with chemotherapy for patients newly diagnosed with Acute Myeloid LeukaemiaA 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)

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 patients with Acute Myeloid Leukaemia.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

CPKC412E2301

More information

Trial Identifiers

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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)

Eligibility

Inclusion

  1. Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL with PML-RARA are not eligible.
  2. Suitability for intensive induction chemotherapy in the judgment of the investigator
  3. 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
  4. Age ≥18 years
  5. Laboratory values that indicate adequate organ function assessed locally at the screening visit

Exclusion

  1. Central nervous system (CNS) leukemia
  2. Therapy-related secondary AML
  3. Isolated extramedullary leukemia
  4. Prior therapy for leukemia or myelodysplasia
  5. AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
  6. Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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