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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Brief Summary

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

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Detailed Description

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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

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Chronic Lymphocytic Leukemia CLL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oblimerson sodium, G3139

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No