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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, CLL

Thank you

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 CenterHouston, Texas  77030-4096
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
San Antonio Cancer InstituteSan Antonio, Texas  78229-3264