Ignite Creation Date:
2024-05-05 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00603668
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2008-01-08
Brief Title:
Phase III Study of Different Doses and Dose Schedules of Milatuzumab hLL1 in CLL
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase III Study of Immunotherapy With Milatuzumab hLL1 in Patients With Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2013-03
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 study will test different doses of anti-CD74 antibody in patients with NHL andor CLL
Detailed Description:
Milatuzumab hLL1 IMMU-115 a humanized anti-CD74 monoclonal antibody Dose escalation will utilize 4 planned dose regimens with 40 or 80 mgkg doses administered intravenously either twice weekly days 1 and 4 or thrice weekly days 1 3 and 5 for 4 consecutive weeks The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab
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