Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022321
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-08-10
Brief Title:
Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study Of The Safety And Efficacy Of Two Dose Schedules Of Gemcituzumab Ozogamicin In Patients With Intermediate-2 Or High-Risk Myelodysplastic Syndromes
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Randomized phase II trial to study the effectiveness of gemtuzumab in treating patients who have myelodysplastic syndrome
PURPOSE Randomized phase II trial to study the effectiveness of gemtuzumab in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the total survival of patients with intermediate-2 or high-risk myelodysplastic syndrome treated with gemtuzumab ozogamicin II Assess the quality of life of patients treated with this drug III Compare two different dose schedules of this drug in these patients IV Determine the safety of this drug in these patients V Determine the number of patients treated with this drug that achieve complete remission partial remission stable disease major and minor hematologic improvements or major and minor cytogenetic responses VI Determine the progression-free survival relapse-free survival and time to progression to acute myeloid leukemia in patients treated with this drug VII Determine the number of transfusions number of days on IV antibiotics and the number of days hospitalized in patients treated with this drug VIII Determine the possible predictors of response in patients treated with this drug including age karyotype and multi-drug resistance efflux IX Determine the pharmacokinetics of this drug in these patients X Correlate the results of pharmacogenomic studies to gene activation and response to therapy in patients treated with this drug
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 60 and under vs over 60 and IPSS score 15-20 vs 25 and greater Patients are randomized to one of two treatment arms Arm I Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 Arm II Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15 After completion of induction therapy patients in both arms with stable or responding disease may receive post-remission therapy comprising up to 3 additional doses of gemtuzumab ozogamicin approximately 28-42 days apart Quality of life is assessed at baseline on day 29 for arm I on day 43 for arm II on day 127 for patients that receive additional doses of study drug and at 8 months for all patients Patients who do not respond to induction therapy are followed monthly for 8 months and then every 3 months thereafter Patients who receive post-remission therapy are followed every 3 months
PROJECTED ACCRUAL Approximately 128 patients 64 per treatment arm will be accrued for this study within 12 months
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 60 and under vs over 60 and IPSS score 15-20 vs 25 and greater Patients are randomized to one of two treatment arms Arm I Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 Arm II Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15 After completion of induction therapy patients in both arms with stable or responding disease may receive post-remission therapy comprising up to 3 additional doses of gemtuzumab ozogamicin approximately 28-42 days apart Quality of life is assessed at baseline on day 29 for arm I on day 43 for arm II on day 127 for patients that receive additional doses of study drug and at 8 months for all patients Patients who do not respond to induction therapy are followed monthly for 8 months and then every 3 months thereafter Patients who receive post-remission therapy are followed every 3 months
PROJECTED ACCRUAL Approximately 128 patients 64 per treatment arm will be accrued for this study within 12 months
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 |
|---|---|---|---|
| NCI-G01-1996 | None | None | None |
| UCLA-0012052 | None | None | None |
| W-AR-0903B1-207-US | None | None | None |