CPKC412E2301 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

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 Leukaemia.
 

This trial is treating patients with Acute Myeloid Leukaemia.

This is a systemic therapy.

You may be excluded from this trial if:

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

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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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)

Commercial Sponsor

Novartis Pharmaceuticals

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.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Nola Kennedy
n.kennedy@alfred.org.au
03 9076 2217

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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