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Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders
Not Recruiting
Trial ID: NCT00992732
Purpose
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.
Official Title
A Phase 2a Open-Label Multi-Center Study Evaluating HQK-1004 Administered With Valganciclovir in Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Lymphoid Malignancies or Lymphoproliferative Disorders
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
Intervention(s):
drug: HQK-1004
drug: Valganciclovir (may substitute with ganciclovir)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507235535