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

Information source: HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoid Malignancies; Lymphoproliferative Disorders

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

Phase: Phase 2

Status: Terminated

Sponsored by: HemaQuest Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Ron Berenson, MD, Study Director, Affiliation: HemaQuest Pharmaceuticals Inc.

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall response rate

Secondary outcome:

Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations

Overall and progression-free survival

Eligibility

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

LPCH/Stanford, Palo Alto, California 94304, United States

University of California, San Francisco, San Francisco, California 94143, United States

Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Weill Cornell Medical College, New York, New York 10065, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Feigin Center - Center for Cell and Gene Therapy, Houston, Texas 77030, United States

Additional Information

Starting date: May 2010
Last updated: July 28, 2011

Page last updated: August 23, 2015

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