Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283101
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2006-01-25
Brief Title:
A Safety Study in Patients With Chronic Lymphocytic Leukemia
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 12 Multi-Dose Study of SGN-40 Anti-huCD40 mAb in Patients With Chronic Lymphocytic Leukemia
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:
This is an open-label dose-escalation study to determine the tolerability safety profile and antitumor activity of SGN-40 in patients with CLL All patients will receive dose escalation during the first two weeks regardless of cohort designation
Detailed Description:
A minimum of three patients will be entered into each dose-level cohort for five weeks Escalation to the next cohort will occur when three patients have received at least one infusion at the highest scheduled dose level and at least one patient has completed the entire five week dosing schedule Cohorts will be enrolled at a maximal dose level of 3 4 6 or 8 mgkgweek Initial therapy will last for 5 weeks Responding patients will receive additional infusions every two weeks x 4 at the maximal dose for each specific cohort
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