NCT00850057

Pharmacodynamic (PD) Study of Intranodal Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Intranodal injection of Ad-ISF35	Ad-ISF35, a replication-defective recombinant type V adenovirus encoding a recombinant humanized CD154 homolog (ISF35).

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-02-24
• Last updated: 2019-07-12

Locations

1 site across 1 country: United States