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

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ClinicalTrials.gov Identifier: NCT00021749
Recruitment Status : Completed
First Posted : August 6, 2001
Last Update Posted : November 13, 2009
Sponsor:
Information provided by:
Genta Incorporated

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia CLL Drug: Oblimerson sodium, G3139 Phase 1 Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
Study Start Date : January 2001
Actual Primary Completion Date : January 2003






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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021749


Locations
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
San Antonio Cancer Institute
San Antonio, Texas, United States
Sponsors and Collaborators
Genta Incorporated

Publications of Results:
ClinicalTrials.gov Identifier: NCT00021749     History of Changes
Obsolete Identifiers: NCT00021190
Other Study ID Numbers: GL208
G3139
Bcl-2 Antisense
First Posted: August 6, 2001    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by Genta Incorporated:
CLL
Leukemia
Chronic
Cancer
Adult
Lymphocytic
Genasense
G3139
Genta
Bcl-2
Antisense
Oligonucleotide
oblimerson

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Oblimersen
Antineoplastic Agents