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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HQK-1004 + Valganciclovir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HQK-1004 | Drug | 1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Days 21, 42, 84 and 126 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Berenson, MD | HemaQuest Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LPCH/Stanford | Palo Alto | California | 94304 | United States | ||
| University of California, San Francisco |
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| Valganciclovir (may substitute with ganciclovir) | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C033018 | arginine butyrate |
| D000077562 | Valganciclovir |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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