Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
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.
Myeloid Leukemia, Chronic
Myeloid Leukemia, Chronic, Accelerated-Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Drug: Imatinib Mesylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open-Label Study of the Intravenous Administration of Homoharringtonine (CGX-635) Combined With the Oral Administration of Gleevec in the Treatment of Patients With Chronic Myeloid Leukemia (CML) in Chronic, Accelerated, and Blast Phase|
- Proportion of patients with accelerated or blast phase CML who convert to at least chronic phase CML [ Time Frame: Monthly evaluations ] [ Designated as safety issue: No ]
- Tolerance and toxicity of the combined HHT- imatinib mesylate treatment regimen. [ Time Frame: On going ] [ Designated as safety issue: No ]
- Proportion of patients with chronic phase CML who are in hematologic remission (CHR) or improved cytogentics at study onset [ Time Frame: Monthly evaluations ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Homoharringtonine + Imatinib Mesylate
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.
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.
Other Names:Drug: Imatinib Mesylate
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.
Other Name: Gleevac
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114959
|United States, Texas|
|Univ. of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Adam R Craig, M.D., PhD||ChemGenex Pharmaceuticals|
|Principal Investigator:||Jorge Cortes, M.D.||Univ. of TX M.D. Anderson Cancer Center|