Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003131
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
1999-11-01
Brief Title:
CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of 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 patients with acute myeloid leukemia in first relapse
PURPOSE Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse
Detailed Description:
OBJECTIVES I Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia 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 CMA-676 IV over 2 hours on day 1 Patients may receive 1 additional dose of therapy 15 to 28 days later Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse andor death
PROJECTED ACCRUAL 55 evaluable patients will be accrued Enrollment will then be extended for up to an additional 55 patients
OUTLINE This is an open label single arm multicenter study Patients receive CMA-676 IV over 2 hours on day 1 Patients may receive 1 additional dose of therapy 15 to 28 days later Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse andor death
PROJECTED ACCRUAL 55 evaluable patients will be accrued 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-V97-1355 | None | None | None |
| CDR0000065896 | None | None | None |
| UCCRC-8600 | None | None | None |