Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004933
Status:
TERMINATED
Last Update Posted:
2016-07-04
First Post:
2000-03-07
Brief Title:
Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Study of Interferon-Refractory Patients With BCRABL Chronic Myelogenous Leukemia CML Treated With Homoharringtonine NSC 141633 vs Hydroxyurea
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
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 It is not yet known if homoharringtonine is more effective than hydroxyurea for chronic myelogenous leukemia that has not responded to interferon alfa
PURPOSE Randomized phase III trial to compare the effectiveness of homoharringtonine with that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not responded to interferon alfa
PURPOSE Randomized phase III trial to compare the effectiveness of homoharringtonine with that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not responded to interferon alfa
Detailed Description:
OBJECTIVES I Compare the overall survival of interferon alfa refractory chronic myelogenous leukemia patients treated with homoharringtonine to those treated with hydroxyurea II Compare the time to progression of these patients treated with these two drugs III Estimate the complete and major cytogenetic response and describe the serial cytogenetics of these patients treated with these two drugs
OUTLINE This is a randomized study Patients are randomized to receive one of two treatments Arm I Induction Patients receive homoharringtonine IV continuously over 24 hours daily for 14 days Induction continues every 28 days for a maximum of 6 courses or until hematopoietic recovery Maintenance Patients receive homoharringtonine IV continuously over 24 hours daily for 5 days Treatment repeats every 28 days Arm II Induction Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts are achieved Maintenance Patients receive oral hydroxyurea daily every 28 days to maintain acceptable blood counts Treatment in both arms continues for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for a maximum of 10 years
PROJECTED ACCRUAL A total of 480 patients 240 per arm will be accrued for this study within 4 years
OUTLINE This is a randomized study Patients are randomized to receive one of two treatments Arm I Induction Patients receive homoharringtonine IV continuously over 24 hours daily for 14 days Induction continues every 28 days for a maximum of 6 courses or until hematopoietic recovery Maintenance Patients receive homoharringtonine IV continuously over 24 hours daily for 5 days Treatment repeats every 28 days Arm II Induction Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts are achieved Maintenance Patients receive oral hydroxyurea daily every 28 days to maintain acceptable blood counts Treatment in both arms continues for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for a maximum of 10 years
PROJECTED ACCRUAL A total of 480 patients 240 per arm will be accrued for this study within 4 years
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 |
|---|---|---|---|
| CDR0000067617 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |