Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105313
Status:
TERMINATED
Last Update Posted:
2007-06-14
First Post:
2005-03-11
Brief Title:
Study to Evaluate MEDI-507 in Patients With CD2-Positive LymphomaLeukemia
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive LymphomaLeukemia
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For primary objectives we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD and describe the safety and tolerability of MEDI-507
For the secondary objectives we will look at the antitumor activity of MEDI 507 PK serum concentrations and immunogenicity of MEDI-507 as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations
For the secondary objectives we will look at the antitumor activity of MEDI 507 PK serum concentrations and immunogenicity of MEDI-507 as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations
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