The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will result in complete or partial responses in patients with EBV-positive lymphoid malignancies or lymphoproliferative disorders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
900 mg BID oral for 21 days (Days 1-21 of each 21 day cycle). If the subject cannot tolerate or absorb valganciclovir, ganciclovir my be administered instead at 5 mg/kg intravenously BID until the subject can tolerate and absorb valganciclovir.
LPCH/Stanford
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Washington University School of Medicine
Overall response rate
Time frame: Days 21, 42, 84 and 126
Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations
Time frame: through end of treatment (up to Day 126) and 30 days post last dose
Overall and progression-free survival
Time frame: through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose
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St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Feigin Center - Center for Cell and Gene Therapy
Houston, Texas, United States