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A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia


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

Thank you

Trial Information

A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia


Key

Inclusion Criteria:



- Absolute lymphocyte count of > 10,000 cells/mm3 or history of ALC >10,000 cell/mm3

- Platelets > 50,000 cells/mm3

- Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23

- Creatinine < 1.5 mg.dL

Key Exclusion Criteria:

- Less than 3 weeks from any prior major surgery or other therapy for CLL including
radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine,
biologic or vaccine therapy.

- History of autoimmune hemolytic anemia

- Prior allogeneic transplant

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

Outcome Measure:

Safety and complete response rate

Outcome Time Frame:

Monthly for response

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GL217

NCT ID:

NCT00078234

Start Date:

November 2003

Completion Date:

September 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • Leukemia
  • Chronic
  • Cancer
  • Adult
  • Lymphocytic
  • Genasense
  • G3139
  • Genta
  • Bcl-2
  • Antisense
  • Oligonucleotide
  • oblimersen
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Georgetown University Medical Center/Lombardi Cancer CenterWashington, District of Columbia  20007