PKC412 and Daunorubicin/Cytarabine in people with FLT3 mutated AML

• Research type

  Research Study

• Full title

  A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML)

• IRAS ID

  8314

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2006-006852-37

• Clinicaltrials.gov Identifier

  NCT00651261

• Research summary

  Standard therapy for previously untreated patients with acute myeloid leukaemia has been fairly unchanged for 20 years. Patients <60yrs normally receive induction chemotherapy with daunorubicin and cytarabine, followed by consolidation chemotherapy. Some patients don??t respond to the initial therapy or relapse after the initial response. Patients who have a gene in their leukaemia cells called an Ó?FLT3 mutation? are more likely to suffer a relapse within 5 years of their first treatment (or to fail initial therapy). The purpose of this study is to compare the effects of the standard chemotherapy with the combination of standard chemotherapy with the experimental drug midostaurin which targets the FLT3 gene.Participants will be screened for the presence of the FLT3 mutation in the leukaemic cells (by taking a sample of blood and bone marrow). Participants with the mutation will be enrolled into the study and randomised to receive either midostaurin or placebo in addition to standard chemotherapy. Midostaurin /placebo will be taken by mouth twice a day as directed. Neither the participant nor the study doctor will know which treatment they are receiving.Induction therapy consists of chemotherapy on days 1-7, then midostaurin/placebo is taken on days 8-21, followed by 7 days of rest. A bone marrow test is done on day 21 to see if the treatment has worked. The induction therapy may be repeated once.Consolidation therapy consists of four 28 day cycles of chemotherapy on days 1-5, then midostaurin/placebo will be taken on days 8-21, followed by 7 days of rest. A bone marrow test is done on day 21 of the last cycle. If the treatment is working, participant'start continuation therapy, consisting of 12 cycles of 28 days. During each cycle midostaurin/placebo is taken for 2 weeks, followed by 2 weeks of no therapy. After therapy, participants will be followed-up for up to 10 years including bone marrow examinations every 4 months for 2 years.This study will be sponsored Novartis Pharma AG. A total of 500 patients will be enrolled worldwide.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/61

• Date of REC Opinion

  26 Jun 2009

• REC opinion

  Further Information Favourable Opinion