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Due to challenges in recruiting eligible patients under the protocol.
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This study is a multi-center, global, open-label, Phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including Japan, Korea, and Singapore, to reveal the safety, tolerability, dose limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), pharmacokinetics (PK), and preliminary efficacy of BCV in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL).
This study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (Phase 1b part: Up to 18 participants [3 to 6 participants in each of the 3 cohorts], Phase 2 part: 25 participants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brincidofovir twice weekly (BIW) via intravenous infusion | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brincidofovir | Drug | Phase 1b part is dose escalation study evaluating three dose levels of BCV, and participants will be assigned to a dose schedule in the order of study entry. In Phase 2 part, participants will receive BCV BIW at the RP2D (determined in the Phase 1b part). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b part (Dose Escalation Part) | Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs | 28 days |
| Phase 2 part (Expansion Part) | Best Overall Response as of end of treatment | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | China | ||||
| Tokyo Metropolitan Komagome Hospital |
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| Bunkyō City |
| Japan |
| National Cancer Center Hospital | Chūōku | Japan |
| Cancer Institute Hospital Of JFCR | Kōtoku | Japan |
| Kyoto University Hospital | Kyoto | Japan |
| Okayama University Hospital | Okayama | Japan |
| Mie University Hospital | Tsu | Japan |
| National Cancer Centre Singapore | Singapore | Singapore |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008223 | Lymphoma |
| D020031 | Epstein-Barr Virus Infections |
| D007119 | Immunoblastic Lymphadenopathy |
| D016399 | Lymphoma, T-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D000072281 | Lymphadenopathy |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015458 | Leukemia, T-Cell |
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| ID | Term |
|---|---|
| C525733 | brincidofovir |
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