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

This study has been completed.
Sponsor:
Information provided by:
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00021749
First received: August 3, 2001
Last updated: November 10, 2009
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 3, 2001
Last Updated: November 10, 2009
Health Authority: United States: Food and Drug Administration

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, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013