HOVON 142 (FL)

a prospective, interventional, randomized, two arms, study evaluating both the depth of the molecular response and the rate of treatment free remission rate in newly diagnosed CP-CML patients treated with NIL or IM followed by switch to NIL in absence of optimal response (defined according the ELN 2013 criteria) as per clinical practice

Study treatments

Nilotinib versus imatinib

Inclusion criteria

• Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase
  • Documented chronic phase CML must meet all the following criteria:
    •  < 15% blasts in peripheral blood
    • < 30% blasts plus promyelocytes in peripheral blood
    • < 20% basophils in the peripheral blood
    • ≥ 100 x 109/L (≥ 100,000/mm3) platelets
• Age ≥18
• ECOG performance status of 0-2
• Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
  
  

Exclusion criteria

• Previous treatment with BCR-ABL inhibitors for more than 30 days
• Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening. 

Participating sites

• Cliniques Universitaires Saint-Luc