Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006265
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2000-09-11
Brief Title:
Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin CMA-676 Mylotarg With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2016-07
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 Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin CMA-676 and high-dose cytarabine
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a dose-escalation study of gemtuzumab ozogamicin CMA-676 phase I closed to accrual effective 08252003 Patients are stratified according to disease status refractory vs relapsed
Phase I closed to accrual effective 08252003 Patients are enrolled in one of four cohorts
Cohort I closed to accrual as of 10102 Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8
Cohort IA open to accrual as of 101502 Patients receive high-dose cytarabine HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7
Cohort II Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14
Cohort IV Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II
Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity
Phase II Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 one course
Patients are followed at 1 month monthly for 6 months every 3 months for 2 years and then annually for 10 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years Phase I closed to accrual effective 08252003
Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin CMA-676 and high-dose cytarabine
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a dose-escalation study of gemtuzumab ozogamicin CMA-676 phase I closed to accrual effective 08252003 Patients are stratified according to disease status refractory vs relapsed
Phase I closed to accrual effective 08252003 Patients are enrolled in one of four cohorts
Cohort I closed to accrual as of 10102 Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8
Cohort IA open to accrual as of 101502 Patients receive high-dose cytarabine HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7
Cohort II Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14
Cohort IV Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II
Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity
Phase II Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 one course
Patients are followed at 1 month monthly for 6 months every 3 months for 2 years and then annually for 10 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years Phase I closed to accrual effective 08252003
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 |
|---|---|---|---|
| CDR0000068208 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-19902 | None | None | None |