A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
Sponsor study identifier
interventional
1
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
Not reported
Date not reportedThe purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2009
Actual (reported)June 10, 2009
Actual (reported)September 2009
Actual (reported)Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.)
1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Adam Lerner, M.D.
Boston University School of Mediciine
1 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
900 mg BID for 16 days (Days 6-21 of each 21 day cycle)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Last Updated
August 1, 2011
Record last verified: 2011-07
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Source: ClinicalTrials.gov.
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