NCT00021749

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

2 years

First QC Date

August 3, 2001

Last Update Submit

November 10, 2009

Conditions

Chronic Lymphocytic LeukemiaCLL

Keywords

CLLLeukemiaChronicCancerAdultLymphocyticGenasenseG3139GentaBcl-2AntisenseOligonucleotideoblimerson

Interventions

Oblimerson sodium, G3139DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

San Antonio Cancer Institute

San Antonio, Texas, United States

Location

Related Publications (1)

  • O'Brien SM, Cunningham CC, Golenkov AK, Turkina AG, Novick SC, Rai KR. Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol. 2005 Oct 20;23(30):7697-702. doi: 10.1200/JCO.2005.02.4364. Epub 2005 Sep 26.

    PMID: 16186597RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemiaBronchiolitis Obliterans SyndromeNeoplasms

Interventions

oblimersen

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2001

First Posted

August 6, 2001

Study Start

January 1, 2001

Primary Completion

January 1, 2003

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

US(3)