Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283114
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2006-01-25
Brief Title:
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1 Multi-Dose Study of SGN-33 Anti-huCD33 mAb HuM195 Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Phase 1a is an open-label multi-dose single-arm dose-escalation study to define the toxicity profile pharmacokinetics and antitumor activity of SGN-33 in patients with myelodysplastic syndrome MDS acute myelogenous leukemiaAML and CD33 myeloproliferative diseases Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a
Detailed Description:
None
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