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| Sponsor: | ChemGenex Pharmaceuticals |
|---|---|
| Information provided by: | ChemGenex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00114959 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic, Accelerated-Phase Blast Phase Myeloid Leukemia, Chronic, Chronic-Phase |
Drug: Homoharringtonine and Gleevec |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 I.V. Administration of Homoharringtonine Combined With the Oral Administration of Gleevec in the Treatment of Patients With CML in Chronic, Accelerated and Blast Phase |
| Enrollment: | 15 |
| Study Start Date: | June 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Eric Humphriss, Sr. Director of Clinical Affairs, ChemGenex |
| ClinicalTrials.gov Identifier: | NCT00114959 History of Changes |
| Other Study ID Numbers: | CGX-635-CML-201, MDACC protocol #2005-0067 |
| Study First Received: | June 20, 2005 |
| Last Updated: | March 31, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Chronic Disease Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Pathologic Processes |
Disease Attributes Homoharringtonine Harringtonines Imatinib Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |