Phase I/II Study of Genasense in Patients With Chronic NCT00021749

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00021749
Other study ID #	GL208
Secondary ID	G3139Bcl-2 Antis
Status	Completed
Phase	Phase 1/Phase 2
First received	August 3, 2001
Last updated	November 10, 2009
Start date	January 2001

Study information
Verified date	November 2009
Source	Genta Incorporated
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

NCT00021190

Recruitment information / eligibility
Status	Completed
Enrollment	40
Est. completion date
Est. primary completion date	January 2003
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Chronic Lymphocytic Leukemia
CLL
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Intervention

Drug:
• Oblimerson sodium, G3139

Locations
Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	San Antonio Cancer Institute	San Antonio	Texas

Sponsors *(1)*
Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States,

References & Publications (1)

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):7697-7 — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information