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