Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cothera Bioscience, Inc
• Treatments: Bromides

Criteria

Inclusion Criteria:

• Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma

• Relapse or refractory disease after at least two previous lines of therapy

• Measurable disease as defined by RECIL criteria

• ECOG performance status of 0-2

• Acceptable coagulation parameters

Exclusion Criteria:

• Allogeneic transplant within 3 months

• Autologous transplant without resolution of post-transplant cytopenias

• Known CNS involvement

• Average QT/QTc interval duration > 450 msec

• Inadequate marrow, hepatic or renal function

• Unresolved Grade 2 or greater toxicities from prior anticancer therapy

• Radiotherapy within prior 4 weeks

• Requires systemic immunosuppressive therapy

• Positive for Hepatis B or Hepatis C

• Seropositive for HIV