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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
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| Cohort 2 | Experimental | Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
|
| Recommended Phase 2 Dose - Cohort 3 | Experimental | The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sepantronium Bromide | Drug | continuous intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability and recommended Phase 2 dose of sepantronium bromide | Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions | From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | 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 | From first dose through the last dose of study drug, an average of 6 months |
| Complete response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vernon Jiang, PhD | Cothera Bioscience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | ||||
| Sun Yat-sen University Cancer Center |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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Dose range findings study
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Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase |
| From first dose of study drug through the last dose of study drug, an average of 6 months |
| Duration of response | Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression | From first dose of study drug through to time of progression, an average of 6 months |
| Clinical benefit rate | Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase | From first dose of study drug through the last dose of study drug, an average of 6 months |
| Overall survival | 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 | From first dose of study drug through date of death, irrespective of cause, an average of 6 months |
| Progression Free Survival | The time from first dose until relapse, disease progression or death due to any cause | From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months |
| Guangzhou |
| China |
| Henan Cancer Hospital | Henan | China |
| Shanghai East Hospital | Pudong | China |
| Tianjin Cancer Hospital | Tianjin | China |
| Tongji Hospital | Wuhan | China |
| Dong-A University Hospital | Busan | South Korea |
| Inje University Haeundae Paik hospital | Busan | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St.Mary's Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008206 | Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C523798 | sepantronium |
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