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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00021749

Enrollment

Registered

2001-08-06

Start date

2001-01-31

Completion date

Unknown

Last updated

2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, CLL

Keywords

CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139, Genta, Bcl-2, Antisense, Oligonucleotide, oblimerson

Brief 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.

Interventions

DRUGOblimerson sodium, G3139

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026