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

Stopped early · Phase 2

Conditions studied: Lymphoid Malignancies, Lymphoproliferative Disorders

In brief

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.

Key facts

Study ID

NCT00992732

Run by

HemaQuest Pharmaceuticals Inc.

People needed

1

Starts

2010-05-01

Last updated by the study team

2011-08-01

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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