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

This study has been completed.

First Received: August 3, 2001 Last Updated: November 10, 2009 History of Changes

Sponsor:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00021749

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia CLL	Drug: Oblimerson sodium, G3139	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Oblimersen sodium

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Enrollment:	40
Study Start Date:	January 2001
Estimated Study Completion Date:	March 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021749

Locations

United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
San Antonio Cancer Institute
San Antonio, Texas, United States

Sponsors and Collaborators

Genta Incorporated

More Information

Publications:

O'Brien SM, Cunningham CC, Golenkov AK, Turkina AG, Novick SC, Rai KR. Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol. 2005 Oct 20;23(30):7697-702. Epub 2005 Sep 26.

Study ID Numbers:	GL208, G3139, Bcl-2 Antisense
Study First Received:	August 3, 2001
Last Updated:	November 10, 2009
ClinicalTrials.gov Identifier:	NCT00021749 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

CLL
Leukemia
Chronic
Cancer
Adult
Lymphocytic
Genasense

G3139
Genta
Bcl-2
Antisense
Oligonucleotide
oblimerson

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on November 27, 2009