Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response

Inclusion Criteria:

• Patients ≥ 18 years of age
• BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy
• CHR, CCyR after at least 18 months of imatinib treatment

• Adequate organ function, defined as the following:

  • total bilirubin < 1.5 x ULN,
  • AST and ALT < 2.5 x ULN,
  • creatinine < 1.5 x ULN,
  • ANC > 1.5 x 109/L,
  • platelets > 100 x 109/L
• Written, voluntarily signed informed consent

Exclusion Criteria:

• CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
• Patient has received any other investigational treatment within 28 days before study entry
• Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
• ECOG performance status ≥ 3
• Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)
• Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)
• Acute chronic infections
• Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)
• Female patients who are pregnant or breast-feeding
• Known diagnosis of HIV