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

Genta Incorporated40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia CLL

Interventions

Oblimerson sodium, G3139DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Locations (3)

Long Island Jewish Medical Center

New Hyde Park, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

San Antonio Cancer Institute

San Antonio, Texas, United States

Data from ClinicalTrials.gov

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