Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003673
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
1999-11-01
Brief Title:
CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia AML in First Relapse
Status:
COMPLETED
Status Verified Date:
2012-08
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 II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission
PURPOSE Phase II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission
Detailed Description:
OBJECTIVES I Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission II Assess the safety of CMA-676 in this patient population
OUTLINE This is an open label single arm multicenter study Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period Patients may receive 1 additional course of therapy 15 to 28 days later There is a 28 day follow-up period after the last dose of study medication Patients are followed for an additional 6 months then every 3 months for 18 months and then every 6 months until relapse andor death
PROJECTED ACCRUAL A total of 23-55 patients will be accrued for this study within 12 months Enrollment will then be extended for up to an additional 55 patients
OUTLINE This is an open label single arm multicenter study Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period Patients may receive 1 additional course of therapy 15 to 28 days later There is a 28 day follow-up period after the last dose of study medication Patients are followed for an additional 6 months then every 3 months for 18 months and then every 6 months until relapse andor death
PROJECTED ACCRUAL A total of 23-55 patients will be accrued for this study within 12 months Enrollment will then be extended for up to an additional 55 patients
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-V98-1497 | None | None | None |
| CDR0000066771 | None | None | None |