Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders

Phase 2

Terminated

Interventions: Drug: HQK-1004
Drug: Valganciclovir (may substitute with ganciclovir)

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed lymphoid malignancy or lymphoproliferative disorder with EBV detected by either immunohistochemistry or in situ hybridization. Pathology can be assessed on either a current or previous biopsy. All disease stages are eligible
Disease that is refractory or relapsed after at least one prior standard therapeutic regimen, which includes biologic agents (e.g., monoclonal antibodies), chemotherapy or chemoradiotherapy regimens. Prior therapy may include high dose chemotherapy and stem cell rescue or bone marrow transplantation
Bidimensionally measurable disease by computerized tomography (CT) or magnetic resonance imaging (MRI; patients with sensitivity to contrast or for tumor types that are less accurately measured by CT) scan or physical measurement (cutaneous lesions only) with at least 1 lesion ≥ 10 mm in the greatest diameter. PET-CT should be used at baseline for patients with Hodgkin's Disease (HD) or diffuse large B-cell lymphoma (DLBCL).
Absolute neutrophil count ≥ 500/mm3 and platelet count ≥ 50,000/mm3
Bilirubin ≤ 2.0 times upper limit of normal (ULN) with the exception of patients with Gilbert's syndrome (bilirubin ≤ 3.5 times ULN allowed), and both AST and ALT ≤ 3 times ULN
Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria

Patients who have not recovered from previous treatment with chemotherapy
Patients who have been treated with biologic agents within two weeks prior to first dose of HQK-1004
Uncontrolled ischemic heart disease or uncontrolled congestive heart failure, or myocardial infarction within the past 3 months

Arm && Interventions

Group	Intervention	Description
HQK-1004 + Valganciclovir	HQK-1004	-
HQK-1004 + Valganciclovir	Valganciclovir (may substitute with ganciclovir)	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	Days 21, 42, 84 and 126

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations	through end of treatment (up to Day 126) and 30 days post last dose
Overall and progression-free survival	through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose

Locations (8): Abramson Cancer Center of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
LPCH/Stanford
🇺🇸
Palo Alto, California, United States
Weill Cornell Medical College
🇺🇸
New York, New York, United States
Feigin Center - Center for Cell and Gene Therapy
🇺🇸
Houston, Texas, United States
Northwestern University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States