Status:
ACTIVE_NOT_RECRUITING
Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
Lead Sponsor:
Cothera Bioscience, Inc
Conditions:
High-grade B-cell Lymphoma
Burkitt Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Detailed Description
This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL. Cohorts of three patients will b...
Eligibility Criteria
Inclusion
- Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
- Relapse or refractory disease after at least one previous line of therapy
- Measurable disease as defined by 2014 Lugano classification
- ECOG performance status of 0-2
- Acceptable coagulation parameters
Exclusion
- 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
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05263583
Start Date
December 9 2022
End Date
June 30 2025
Last Update
January 14 2025
Active Locations (11)
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1
Beijing Cancer Hospital
Beijing, China
2
Sun Yat-sen University Cancer Center
Guangzhou, China
3
Henan Cancer Hospital
Henan, China
4
Shanghai East Hospital
Pudong, China