Back to resultsPhase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia, CLL
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oblimerson sodium, G3139
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139, Genta, Bcl-2, Antisense, Oligonucleotide, oblimerson
Eligibility 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
Sites / Locations
- Long Island Jewish Medical Center
- MD Anderson Cancer Center
- San Antonio Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00021749
Brief Title
Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Official Title
Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genta Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, CLL
Keywords
CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139, Genta, Bcl-2, Antisense, Oligonucleotide, oblimerson
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oblimerson sodium, G3139
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
San Antonio Cancer Institute
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16186597
Citation
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. doi: 10.1200/JCO.2005.02.4364. Epub 2005 Sep 26.
Results Reference
result
Learn more about this trial
Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
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