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A phase II multicentre, single-arm, open-label study of subcutaneous hemi-synthetic homoharringtonine (HHT) alone in patients with accelerated phase chronic myeloid leukemia (CML) who are refractory to, or have relapsed on imatinib mesylate.
  Protocol : HHT-CML/INTL/04.2
  Investigator Coordinator : Dr Frederic Maloisel CHU Strasbourg France & Dr David Marin, Hammersmith Hospital, London United Kingdom
 
Primary Objectives
 

To assess the efficacy and safety of subcutaneous homoharringtonine (HHT) in the management patients with accelerated phase CML who have proved to be refractory, or resistant to imatinib mesylate.

  
 
  Selected Inclusion Criteria  
  a) Male or female patients aged 18 to 80 years.

b) Patients diagnosed with Ph chromosome-positive or BCR-ABL positive CML in the accelerated phase confirmed by a bone marrow aspirate and/or biopsy including cytogenetics and molecular analysis that must be completed within 28 days prior to initiation of homoharringtonine (HHT).

c) Patients who have failed to respond to, or have relapsed on imatinib (see Appendix 1 for definition).

  
 
  Selected Exclusion Criteria  
 

a) Patients planned for allogeneic transplantation before end of induction period

b) Prior stem cell transplantation

c) Patients previously treated with combination chemotherapy or auto grafting for accelerated phase disease

d) Patients with previous blastic phase

e) Patients previously treated with Homoharringtonine (HHT)

f) Female patients who are pregnant (confirmed by a serum pregnancy test) or lactating

  
 
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