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

NCT00850057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

Intranodal injection of Ad-ISF35

Ad-ISF35, a replication-defective recombinant type V adenovirus encoding a recombinant humanized CD154 homolog (ISF35).

Sponsors & Collaborators

Principal Investigators

  • Januario Castro, M.D. · Assistant Clinical Professor in the Blood and Marrow Transplantation Division

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850057 on ClinicalTrials.gov