Treatment with Brincidofovir for patients with relapsed lymphoma
A Multi-Center, Global, Open-Label, Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma As Well As to Evaluate the Safety and Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma Using The Recommended Phase 2 Dose
PHASE1; PHASE2 · SymBio Pharmaceuticals · NCT06761677
This study is testing if a new drug called Brincidofovir can help people with relapsed lymphoma feel better and improve their treatment options.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SymBio Pharmaceuticals (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Chuo-ku and 3 other locations) |
| Trial ID | NCT06761677 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, global, open-label study assessing the safety and efficacy of Brincidofovir in patients with relapsed or refractory lymphoma, including Extranodal Natural Killer/T-cell Lymphoma (ENKL). The study is divided into two parts, with a total enrollment of up to 43 participants, focusing on determining the maximum tolerated dose and preliminary efficacy of the treatment. Participants will be monitored for safety, tolerability, and pharmacokinetics of the drug across various cohorts. The trial is being conducted in multiple countries, including Japan, Korea, and Singapore.
Who should consider this trial
Good fit: Ideal candidates include patients with histopathologically confirmed relapsed or refractory lymphoma who have previously undergone systemic chemotherapy.
Not a fit: Patients who have not been previously treated with systemic chemotherapy or those with other types of lymphoma not specified in the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory lymphomas.
How similar studies have performed: While this approach is novel for this specific patient population, similar studies have shown promise in treating other types of lymphoma with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * Patients with another active malignant tumor requiring treatment * Patients with 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 Cidofovir intolerance * Patients with a history of being diagnosed with cirrhosis
Where this trial is running
Chuo-ku and 3 other locations
- National Cancer Center Hospital — Chuo-ku, Japan (RECRUITING)
- Cancer Institute Hospital Of JFCR — Koto-ku, Japan (RECRUITING)
- Okayama University Hospital — Okayama, Japan (RECRUITING)
- Mie University Hospital — Tsu, Japan (RECRUITING)
Study contacts
- Study coordinator: Kohji Shimasaki
- Email: MedInfo@symbiopharma.com
- Phone: +81-3-5472-1127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed or Refractory Lymphoma Including ENKL, SyB V-1901, BCV, Relapsed or refractory Lymphoma, Extranodal Natural Killer/T-cell Lymphoma, ENKL, EBV-positive nodal T- and NK-cell lymphoma, EBV + nTNKCL