Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
- Conditions
- Lymphoma, B-CellLymphoma, Large B-Cell, DiffuseHigh-grade B-cell LymphomaLymphatic DiseasesBurkitt LymphomaC-MYC/BCL2 Double-Hit High-Grade B-Cell LymphomaLymphoma, High-GradeC-MYC/BCL6 Double-Hit High-Grade B-Cell LymphomaC-Myc Gene Rearrangement
- Interventions
- Registration Number
- NCT05263583
- Lead Sponsor
- Cothera Bioscience, Inc
- 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 be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.
Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.
An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 Sepantronium Bromide Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide Cohort 2 Sepantronium Bromide Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide Recommended Phase 2 Dose - Cohort 3 Sepantronium Bromide The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2
- Primary Outcome Measures
Name Time Method Safety and tolerability and recommended Phase 2 dose of sepantronium bromide From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions
- Secondary Outcome Measures
Name Time Method Overall response rate From first dose through the last dose of study drug, an average of 6 months The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase
Complete response rate From first dose of study drug through the last dose of study drug, an average of 6 months Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase
Duration of response From first dose of study drug through to time of progression, an average of 6 months Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression
Clinical benefit rate From first dose of study drug through the last dose of study drug, an average of 6 months Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase
Overall survival From first dose of study drug through date of death, irrespective of cause, an average of 6 months The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients
Progression Free Survival From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months The time from first dose until relapse, disease progression or death due to any cause
Trial Locations
- Locations (11)
Beijing Cancer Hospital
🇨🇳Beijing, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Tongji Hospital
🇨🇳Wuhan, China
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik hospital
🇰🇷Busan, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Henan Cancer Hospital
🇨🇳Henan, China
Shanghai East Hospital
🇨🇳Pudong, China
Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of