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

Genta Incorporated

Status and phase: Completed; Phase 2; Phase 1

Conditions: CLL; Chronic Lymphocytic Leukemia

Treatments: Drug: Oblimerson sodium, G3139

Study type: Interventional

Funder types: Industry

Identifiers

NCT00021749

GL208

G3139

Bcl-2 Antisense

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Any age
• Must have received at least one chemotherapy regimen that included fludarabine
• Measurable disease
• At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
• No previous stem cell transplantation
• At least 3 weeks since surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)