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

Plain-language summary

This study investigates the drug Sepantronium Bromide in the treatment of c-Myc rearranged high-grade B-cell lymphoma. It enrolled patients with measurable, relapsed or refractory disease after at least one prior line of therapy. It is being conducted in Phase 2 and is active but not currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Cothera Bioscience, Inc

Intervention

Sepantronium Bromide

Start date

12/9/2022

Estimated completion

6/30/2025

Countries

China, South Korea

Related genes

Locations

• Beijing, China
• Guangzhou, China
• Henan, China
• Pudong, China
• Tianjin, China
• Wuhan, China
• Busan, South Korea
• Busan, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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