Clinical Trials Directory

Trials / Completed

CompletedNCT00021749

Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Genta Incorporated · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Detailed description

This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL. Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

Conditions

Interventions

TypeNameDescription
DRUGOblimerson sodium, G3139

Timeline

Start date
2001-01-01
Primary completion
2003-01-01
First posted
2001-08-06
Last updated
2009-11-13

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00021749. Inclusion in this directory is not an endorsement.