Clinical trial · Interventional
Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)
NCT05263583CI-TRIAL-00084675active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma | — | UNRESOLVED | — |
| C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma | — | UNRESOLVED | — |
| C-Myc Gene Rearrangement | — | UNRESOLVED | — |
| High-grade B-cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Lymphatic Diseases | — | UNRESOLVED | — |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, High-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sepantronium Bromide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide
- interventionNames
- Drug: Sepantronium Bromide
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide
- interventionNames
- Drug: Sepantronium Bromide
- type
- EXPERIMENTAL
- label
- Recommended Phase 2 Dose - Cohort 3
- description
- The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.