Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030355
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2002-02-14
Brief Title:
Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Open-Label Study Of The Intravenous Administration Of Homoharringtonine CGX-635 Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia
PURPOSE Phase III trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia
Detailed Description:
OBJECTIVES
Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia
Determine the antileukemic efficacy of this drug in these patients
OUTLINE Patients receive remission induction therapy comprising homoharringtonine HH IV continuously on days 1-14 Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission CR is achieved or the patient fails to respond after 3 courses
Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7 Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study
Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia
Determine the antileukemic efficacy of this drug in these patients
OUTLINE Patients receive remission induction therapy comprising homoharringtonine HH IV continuously on days 1-14 Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission CR is achieved or the patient fails to respond after 3 courses
Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7 Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-DM-01265 | None | None | None |
| CHEMGENEX-CGX-635-APL-101 | None | None | None |