Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT00850057
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2009-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic (PD) Study of Intranodal Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
A Phase 1, Open Label, Dose-escalation, Pharmacodynamic Study of Intranodal Injection of Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Primary Objectives
* To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when it is injected directly into the lymph nodes of patients with CLL or SLL.
Secondary Objectives
* To determine and monitor clinical and biological responses in patients treated with injections of Ad-ISF35.
* To determine how ISF35 works in CLL/SLL patients' cells.
* To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when it is injected directly into the lymph nodes of patients with CLL or SLL.
Secondary Objectives
* To determine and monitor clinical and biological responses in patients treated with injections of Ad-ISF35.
* To determine how ISF35 works in CLL/SLL patients' cells.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: