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

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

Completed

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Key information

Conditions

Chronic Lymphocytic Leukemia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis CLL Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Long Island Jewish Medical Center, New Hyde Park, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oblimerson sodium, G3139

Drug

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2003
First posted: Aug 6, 2001
Registry last updated: Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed