A Phase 1b/2 Study of IV Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma (BCV-NL01)

JRCT ID: jRCT2061240096

Registered date:24/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or refractory lymphoma including ENKL
• Date of first enrollment: 20/12/2024
• Target sample size: 43
• Countries of recruitment: Korea,Japan,Singapore,Japan,Hong Kong,Japan
• Study type: Interventional

Intervention(s)

Phase 1b part:
- The BCV dose will be escalated using the 3+3 design, evaluate the DLTs of BCV in groups of 3 participants in each cohort (intravenous infusion of any of the doses in cohorts 1-3, twice a week), and investigate the recommended dosage and administration prior to the start of the Phase 2 part.

Phase 2 part:
- BCV RP2D determined in the Phase Ib part will be administered via intravenous infusion twice weekly.

Outcome(s)

Primary Outcome

- (Phase 1b Part only) Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs
- Incidence of treatment-emergent adverse events (TEAEs) after initiation of BCV treatment (particularly the incidence of AEs and serious adverse events [SAE] of NCI-CTCAE Grade 3 or higher)
- (Phase 2 Part only) Best Overall Response as of end of treatment (EOT)
- PK exposure dose by participants estimated using population PK analysis (maximum plasma concentration [Cmax] and the area under the concentration-time curve [AUC], etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients who are histopathologically diagnosed with ENKL based on the World Health Organization (WHO) Classification of Malignant Lymphoma 5th Edition (WHO-HAEM5) (can be enrolled in the Phase 1b part and the Phase 2 part) or patients diagnosed with EBV-positive nodal T- and NK-cell lymphoma (EBV + nTNKCL), nodal T-follicular helper cell lymphoma (nTFHcL) (including angioimmunoblastic T-cell lymphoma (AITL) as defined in the WHO Classification, 4th Edition), peripheral T-cell lymphoma not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), diffuse large B-cell lymphoma (DLBCL) (e.g., DLBCL, NOS), or adult T-Cell Leukemia Lymphoma (ATLL) (can only be enrolled in the Phase 1b part)
- Patients with relapsed or refractory lymphoma and previously treated with systemic chemotherapy (history of multidrug chemotherapy including L-asparaginase such as SMILE therapy for ENKL is mandatory) who are ineligible for other systemic therapies
- Patients with the following Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
- Phase 1b part: 0-1
- Phase 2 part: 0-2

Exclude criteria

- Patients with another active malignant tumor requiring treatment
- Patients with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2 or higher diarrhea (increase of 4 or more bowel movements per day compared to usual number of bowel movements) within 7 days prior to starting the first dose of BCV
- Graft-Versus-Host Disease (GVHD) patients requiring immunosuppressive agents
- Patients with a history of CDV intolerance
- Patients with a history of being diagnosed with cirrhosis

Related Information

• Primary Sponsor: Tobinai Kensei