Sepantroniumbromid for behandling av høygradig B-celle lymfom
En fase 2, multisenter, åpen etikettdosestudie av sepantroniumbromid hos pasienter med residiverende/refraktær c-Myc rearrangert høygradig B-celle lymfom (HGBCL)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
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Beijing, Kina
- Beijing Cancer Hospital
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Guangzhou, Kina
- Sun Yat-sen University Cancer Center
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Henan, Kina
- Henan Cancer Hospital
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Pudong, Kina
- Shanghai East Hospital
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Tianjin, Kina
- Tianjin Cancer Hospital
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Wuhan, Kina
- Tongji Hospital
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-
-
-
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Busan, Sør -Korea
- Dong-A University Hospital
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Busan, Sør -Korea
- Inje University Haeundae Paik hospital
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Seoul, Sør -Korea
- Samsung Medical Center
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Seoul, Sør -Korea
- Seoul National University Hospital
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Seoul, Sør -Korea
- Seoul St.Mary's Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Andre navn:
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Eksperimentell: Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Andre navn:
|
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Eksperimentell: Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
continuous intravenous infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
Tidsramme: 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 |
From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall response rate
Tidsramme: 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 |
From first dose through the last dose of study drug, an average of 6 months
|
|
Complete response rate
Tidsramme: 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 |
From first dose of study drug through the last dose of study drug, an average of 6 months
|
|
Duration of response
Tidsramme: 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 |
From first dose of study drug through to time of progression, an average of 6 months
|
|
Clinical benefit rate
Tidsramme: 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 |
From first dose of study drug through the last dose of study drug, an average of 6 months
|
|
Overall survival
Tidsramme: 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 |
From first dose of study drug through date of death, irrespective of cause, an average of 6 months
|
|
Progression Free Survival
Tidsramme: 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 |
From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Vernon Jiang, PhD, Cothera Bioscience
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer
- Sykdomsattributter
- Sykdommer i immunsystemet
- Infeksjoner
- Virussykdommer
- Neoplasmer etter histologisk type
- DNA-virusinfeksjoner
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom
- Epstein-Barr-virusinfeksjoner
- Herpesviridae-infeksjoner
- Tumorvirusinfeksjoner
- Patologiske tilstander, tegn og symptomer
- Hemic og lymfatiske sykdommer
- Tilbakefall
- Lymfom, B-celle
- Lymfom, stor B-celle, diffus
- Burkitt lymfom
- Lymfom, Non-Hodgkin
- Lymfesykdommer
- sepantronium
Andre studie-ID-numre
- PC002-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD-delingstidsramme
Beginning 9 months and ending 36 months following article publication.
Tilgangskriterier for IPD-deling
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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