Trial Information

Summary: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (HHT) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutation (Protocol CGX-635-CML-202)

A large percentage of patients who have failed imatinib therapy have been found to have a point mutation in the BCR-ABL gene, referred to as T315I, which results in the CML stems cells being highly resistant to imatinib, as well as to dasatinib. CML patients with this gene mutation, therefore, do not respond to treatment with either imatinib or dasatinib. In in vitro studies, HHT is active against leukemia cells that have been transfected with the T315I gene mutation, and in Phase 2 studies, HHT has demonstrated clinical activity in patients with CML, both as a single agent and in-combination with other chemotherapeutic drugs.

This study will enroll patients who have Chronic, Accelerated, or Blast Phase CML who have failed treatment with imatinib and have the T315I gene mutation. Patients will be treated with HHT administered subcutaneously (under the skin) injections. The injections may be given at home, and the patient will be closely observed by the medical staff while on study.

Key Eligibility Criteria:

• Male or female patients, age 18 years or older
• Philadelphia chromosome (Ph) positive chronic myeloid leukemia (CML) in either chronic, accelerated, or blast phase
• The patient will have the T315I BCR-ABL gene mutation.
• Patients will have failed prior imatinib therapy,
• ECOG performance status 0-2

Key Exclusion Criteria:

• NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure.
• Myocardial infarction in the previous 12 weeks.
• Lymphoid Ph+ blast crisis

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.