Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia, CLL
Trial Information
Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
GL208
NCT ID:
NCT00021749
Start Date:
January 2001
Completion Date:
Related Keywords:
- Chronic Lymphocytic Leukemia
- CLL
- CLL
- Leukemia
- Chronic
- Cancer
- Adult
- Lymphocytic
- Genasense
- G3139
- Genta
- Bcl-2
- Antisense
- Oligonucleotide
- oblimerson
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| San Antonio Cancer Institute | San Antonio, Texas 78229-3264 |
