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



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

For Condition: Chronic Lymphocytic Leukemia,CLL
Status: Recruiting
Sponsor(s): Genta ,
Synopsis: This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 49

Location and Contact Information:

Long Island Jewish Medical Center *Recruiting*
New Hyde Park,  New York, 
United States
Recruiting Patient  Recruiter 888-322-2264

MD Anderson Cancer Center *Recruiting*
Houston,  Texas, 
United States
Recruiting Patient  Recruiter 888-322-2264

San Antonio Cancer Institute *Recruiting*
San Antonio,  Texas, 
United States
Recruiting Patient  Recruiter 888-322-2264

US Oncology *Recruiting*
Dallas,  Texas, 
United States
Recruiting Patient  Recruiter 888-322-2264

Ohio State University James Cancer Center *Not yet recruiting*
Columbus,  Ohio, 
United States
Not yet recruiting Patient  Recruiter 888-322-2264


Additional Information:
Study ID Numbers:
  GL208;  G3139,Bcl-2 Antisense
Study Start Date: January 2001
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021749

Other Chronic Lymphocytic Leukemia Studies:
1. Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

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