Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114959
Status:
TERMINATED
Last Update Posted:
2015-01-15
First Post:
2005-06-20
Brief Title:
Homoharringtonine With Oral Gleevec in Chronic Accelerated and Blast Phase Chronic Myeloid Leukemia CML
Sponsor:
ChemGenex Pharmaceuticals
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDACC protocol 2005-0067 | OTHER | MD Anderson Cancer Center | None |