Clinical trial NCT00114959
Conditions: Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic, Accelerated-Phase Blast Phase Myeloid Leukemia, Chronic, Chronic-Phase
Keywords: ChemGenex Pharmaceuticals, Ltd ChemGenex Pharmaceuticals ChemGenex Chronic Myeloid Leukemia Myeloid Leukemia, Chronic Leukemia Myeloid Leukemia Chronic Phase Accelerated Phase Blast Phase Myeloid, Leukemia, Chronic, Accelerated Phase Myeloid, Leukemia, Chronic Leukemia, Myeloid, Chronic Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Chronic Phase Leukemia, Myeloid, Accelerated-Phase Myeloid, Leukemia, Chronic, Chronic Phase Leukemia, Myeloid, Accelerated Phase Homoharringtonine Omacetaxine
Sponsor: ChemGenex Pharmaceuticals
Start date: 2005-10-01; Completion date: 2009-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec, adding Homoharringtonine may restore a response to Gleevec or the combined treatment may promote a better response than using Gleevec alone.

Detailed description:
Every 4 weeks, the study medicine Homoharringtonine will be given by vein daily for 5 days along with continuing daily doses of the approved medicine Gleevec taken by mouth. The safety and effectiveness of this combined treatment in CML patients will be studied. Patients who do not achieve a meaningful hematologic or cytogenetic response after 4 cycles or less will be discontinued. Otherwise, patients may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Arms: arm 1: Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Interventions: intervention 1: Homoharringtonine intervention 2: Imatinib Mesylate
Intervention descriptions: intervention 1: Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles.

Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m\^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule. intervention 2: Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.

Protocol documents: