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

Tracking Information
First Received Date ^ICMJE	August 3, 2001
Last Updated Date	November 10, 2009
Start Date ^ICMJE	January 2001
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00021749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Official Title ^ICMJE	Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
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.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Lymphocytic Leukemia CLL
Intervention ^ICMJE	Drug: Oblimerson sodium, G3139
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	March 2003
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00021749
Responsible Party
Study ID Numbers ^ICMJE	GL208, G3139, Bcl-2 Antisense
Study Sponsor ^ICMJE	Genta Incorporated
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genta Incorporated
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP