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

Sponsor

Genta Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00021749

Collaborator

(none)

Enrollment

Locations

13.3

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia CLL	Drug: Oblimerson sodium, G3139	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Long Island Jewish Medical Center	New Hyde Park	New York	United States
2	MD Anderson Cancer Center	Houston	Texas	United States
3	San Antonio Cancer Institute	San Antonio	Texas	United States