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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00021749
First Posted: August 6, 2001
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Genta Incorporated
  Purpose
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Condition Intervention Phase
Chronic Lymphocytic Leukemia CLL Drug: Oblimerson sodium, G3139 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Enrollment: 40
Study Start Date: January 2001
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00021749     History of Changes
Obsolete Identifiers: NCT00021190
Other Study ID Numbers: GL208
G3139
Bcl-2 Antisense
First Submitted: August 3, 2001
First Posted: August 6, 2001
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