Completed

A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia

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What is being tested

Oblimersen-rituximab-fludarabine

Drug
Who is being recruted

Organizing Pneumonia+23

+ Bronchial Diseases

+ Bronchiolitis

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorGenta Incorporated
Last updated: November 7, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.

NCT00078234
Principal SponsorGenta Incorporated
Last updated: November 7, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Organizing PneumoniaBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisChronic DiseaseGraft vs Host DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemia, LymphoidLung DiseasesLung Diseases, ObstructiveLymphatic DiseasesLymphoproliferative DisordersNeoplasms by Histologic TypePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsLeukemia, B-CellDisease AttributesBronchiolitis Obliterans SyndromeLeukemiaNeoplasmsLeukemia, Lymphocytic, Chronic, B-Cell

Criteria

3 exclusion criteria prevent from participating
History of autoimmune hemolytic anemia
Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy
Prior allogeneic transplant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Georgetown University Medical Center/Lombardi Cancer Center

Washington D.C., United StatesOpen Georgetown University Medical Center/Lombardi Cancer Center in Google Maps

Roswell Park Cancer Institute

Buffalo, United States

Long Island Jewish Medical Center

New Hyde Park, United States
Completed3 Study Centers