A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
Sponsor study identifier
Secondary identifiers
interventional
52
1 country
1
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
Not reported
Date not reportedMonoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 9, 2006
Actual (reported)March 13, 2006
Actual (reported)November 2007
Actual (reported)Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response
The true OR rate will be estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 95% exact confidence interval for the true OR rate of each arm reflecting the above two-stage design.
12 months
Toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Up to 10 years
Time-to-progression (TTP)
Up to 10 years
Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and 15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1. Extended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9. Treatment continues for 9 months in the absence of disease progression or unacceptable toxicity.
Given IV
Given IV
Cancer and Leukemia Group B
Chicago, Illinois, 60606, United States
Barbara Grant
Cancer and Leukemia Group B
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Time-to-best response
Up to 10 years
Overall survival
Up to 10 years
Correlative studies
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Last Updated
January 7, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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