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


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

This study is currently recruiting patients.

Sponsored by:	Genta
Information provided by:	Genta

Purpose

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Condition	Treatment or Intervention	Phase
Chronic Lymphocytic Leukemia CLL	Drug: Oblimerson, G3139	Phase I Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase I-II Multicenter Study of Genasense? (Bcl-2 Antisense Oligonucleotide) in Patients with Advanced Chronic Lymphocytic Leukemia

Further Study Details:

Expected Total Enrollment: 49

Study start: January 2001

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

Genders Eligible for Study: Both

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

Location and Contact Information

Patient Recruiter (888) 322-2264 clinicaltrials@genta.com

New York
Long Island Jewish Medical Center, New Hyde Park, New York, United States; Recruiting