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En undersøgelse af Brentuximab Vedotin i kombination med cyclophosphamid, Doxorubicin (Hydroxydaunorubicin), Prednison (CHP) hos kinesiske deltagere med CD30-positive (CD30+) perifere T-celle lymfomer (PTCL)

11. juni 2026 opdateret af: Takeda

En fase 2, single-arm, open-label, multicenter undersøgelse af Brentuximab Vedotin i kombination med cyclophosphamid, doxorubicin (Hydroxydaunorubicin), Prednison (CHP) i frontlinjebehandlingen af ​​kinesiske patienter med CD30-positive (CD30+) perifere T-Cell lymfomer (PTCL)

Denne undersøgelse vil bruge en kombination af Brentuximab vedotin med CHP til at behandle voksne kinesiske deltagere med CD30+ PTCL.

Hovedformålet med undersøgelsen er at evaluere:

  • Bivirkning fra A+CHP
  • Tjek, hvor meget A+CHP forbliver i deres blod over tid. Dette vil hjælpe Takeda med at finde frem til den bedste dosis at give folk i fremtiden.
  • Hvis A+CHP forbedrer resultatet af nydiagnosticeret CD30+ PTCL

Brentuximab vedotin vil blive givet gennem en vene på dag 1 i hver 21-dages cyklus. Cyclophosphamid og doxorubicin vil blive givet gennem vene. Prednison vil blive givet oralt dagligt på dag 1 til 5.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lægemidlet, der testes i denne undersøgelse, kaldes brentuximab vedotin. Brentuximab vedotin testes til behandling af CD30+ PTCL hos kinesiske deltagere. Denne undersøgelse vil se på effektivitet, sikkerhed og farmakokinetik (PK) af A+CHP som frontlinjebehandling af nydiagnosticeret CD30+ PTCL.

Undersøgelsen vil omfatte cirka 52 deltagere. Deltagerne vil blive tilmeldt en enkelt gruppe for at modtage:

• Brentuximab vedotin 1,8 milligram per kilogram (mg/kg) + Cyclophosphamid 750 milligram per kvadratmeter (mg/m^2), Doxorubicin 50 mg/m^2 og Prednison 100 mg

Dette multicenterforsøg vil blive gennemført i Kina. Den samlede tid til at deltage i denne undersøgelse er cirka 36 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100142
        • Beijing Cancer Hospital
      • Beijing, Kina, 100191
        • Peking University Third Hospital
      • Changchun, Kina, 130021
        • The First Hospital of Jilin University
      • Chengdu, Kina, 610041
        • West China Hospital, Sichuan University
      • Chongqing, Kina, 400030
        • Chongqing University Cancer Hospital
      • Fuzhou, Kina, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, Kina, 510080
        • Guangdong Provincial Peoples Hospital
      • Hangzhou, Kina, 310003
        • The First Affiliated Hospital of Zhejiang University school of medicine
      • Hefei, Kina, 230088
        • Anhui Provincial Cancer Hospital
      • Jinan, Kina, 250117
        • Shandong Cancer Hospital
      • Nanchang, Kina, 330006
        • The First Affiliated Hospital of Nanchang University
      • Shanghai, Kina, 200032
        • Fudan University Shanghai Cancer Center
      • Shenyang, Kina, 110022
        • Shengjing Hospital of China Medical University
      • Suzhou, Kina, 215004
        • The First Affiliated Hospital of Soochow University
      • Tianjin, Kina, 300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Zhengzhou, Kina, 450003
        • Henan Cancer Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Deltagerne skal have nydiagnosticeret CD30+ PTCL i henhold til den Reviderede European American Lymphoma 2016 World Health Organization (WHO) klassifikation, efter lokal vurdering. Tumorprøver skal indsendes før tilmelding til efterfølgende central patologigennemgang for at bekræfte histologi (og anaplastisk lymfomkinase (ALK) status, hvis relevant) og CD30-ekspression. Støtteberettigede histologier inkluderer:

    1. ALK-positivt systemisk anaplastisk storcellet lymfom (sALCL) med en International Prognostic Index (IPI) score på ≥2.
    2. ALK-negativ sALCL.
    3. PTCL- ikke andet specificeret (NOS).
    4. Angioimmunoblastisk T-celle lymfom (AITL).
    5. Enteropati associeret T-celle lymfom (EATL).
    6. Hepatosplenisk T-celle lymfom (HSTCL).
  2. Eastern Cooperative Oncology Group (ECOG) præstationsstatus på mindre end eller lig med 2.
  3. Fluorodeoxyglucose (FDG)-ivrig sygdom ved positronemissionstomografi (PET) billeddannelse og målbar sygdom med mindst 1 bidimensionelt målbar læsion (>1,5 cm i sin største dimension) ved computertomografi (CT).
  4. Egnet venøs adgang til den undersøgelseskrævede blodprøvetagning, inklusive farmakokinetisk (PK) og immunogenicitetsprøvetagning.

  5. Kliniske laboratorieværdier som specificeret nedenfor ved screening/baseline inden for 7 dage før den første dosis af forsøgslægemidlet:

    1. Total bilirubin skal være ≤1,5 ​​gange den øvre grænse for normal (ULN) eller ≤3 gange ULN for deltagere med Gilberts sygdom eller dokumenteret leverpåvirkning med lymfom.
    2. Alaninaminotransferase (ALT) og aspartataminotransferase (AST) skal være ≤3 gange ULN eller ≤5 gange ULN for deltagere med en forhøjelse, der med rimelighed kan tilskrives tilstedeværelsen af ​​metastatisk sygdom i leveren.
    3. Serumkreatinin skal være <2,0 milligram pr. deciliter (mg/dL) og/eller kreatininclearance eller beregnet kreatininclearance >40 milliliter (mL)/minut.
    4. Hæmoglobin skal være ≥8 gram pr. deciliter (g/dL). (Transfusion af røde blodlegemer er tilladt ≥14 dage før vurdering.)
    5. Absolut neutrofiltal >1,5×10^9/liter (L).
    6. Blodpladetal ≥75×10^9/L (medmindre der er dokumenteret knoglemarvspåvirkning med lymfom).

Ekskluderingskriterier:

  1. Systemisk anticancerterapi, herunder traditionel kinesisk medicin med antitumorindikation for sygdom, der er under undersøgelse, før den første dosis af undersøgelsesmedicin.
  2. Større operation inden for 28 dage før den første dosis af undersøgelseslægemidlet.
  3. Kendt human immundefektvirus (HIV)-positiv status.

  4. Kendt hepatitis B-virus (HBV) overfladeantigen (HBsAg) seropositivitet eller aktiv hepatitis C-virusinfektion.

    Bemærk: Deltagere, der har positivt HBV-kerneantistof og er HBsAg-negative, kan tilmeldes, men skal have en ikke-detekterbar HBV-virusbelastning.

  5. Diagnosticeret eller behandlet for en anden malignitet inden for 3 år før den første dosis eller tidligere diagnosticeret med en anden malignitet og har tegn på resterende sygdom. Deltagere med ikke-melanom hudkræft eller carcinom in situ af enhver type er ikke udelukket, hvis de har gennemgået fuldstændig resektion.

  6. Enhver af følgende kardiovaskulære tilstande eller værdier inden for 6 måneder før den første dosis af studielægemidlet:

    1. Venstre-ventrikulær ejektionsfraktion <45%.
    2. Myokardieinfarkt inden for 6 måneder efter tilmelding.
    3. New York Heart Association klasse III eller IV hjertesvigt.
  7. Deltagere med aktuel diagnose af primære kutane CD30+ T-celle lymfoproliferative lidelser og lymfomer. Deltagere med kutant anaplastisk storcellet lymfom (ALCL) med ekstrakutan tumor spredt ud over lokoregionale lymfeknuder er kvalificerede (tidligere enkeltstofbehandling til behandling af kutan og lokoregional sygdom er tilladt).
  8. Deltagere med mycosis fungoides (MF) [inklusive transformeret MF].
  9. Ukontrolleret diabetes mellitus.
  10. Baseline perifer neuropati ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0).
  11. Anamnese med progressiv multifokal leukoencefalopati (PML).
  12. Tidligere behandling med brentuximab vedotin eller CD30 monoklonalt antistof.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Brentuximab Vedotin + CHP
Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m^2 and doxorubicin 50 mg/m^2 IV, on Day 1 of each 21-day cycle, and prednisone 100 milligram (mg) tablets, orally, on Days 1 through Day 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurs first.
Medicin: Brentuximab Vedotin
Brentuximab vedotin IV infusion
Medicin: Cyclofosfamid
Cyclophosphamid IV infusion
Medicin: Doxorubicin
Doxorubicin IV infusion
Medicin: Prednison
Prednison tabletter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
Tidsramme: Up to approximately 7 months
ORR by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Tidsramme: Up to approximately 7 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment.
Up to approximately 7 months
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
Tidsramme: Up to approximately 7 months

Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed.

Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Up to approximately 7 months
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)
Tidsramme: Up to approximately 7 months
Up to approximately 7 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
Tidsramme: Up to approximately 7 months
CR rate by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease.
Up to approximately 7 months
1-Year Progression Free Survival (PFS) Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
Tidsramme: Month 12
The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
1-Year Overall Survival (OS) Rate
Tidsramme: Month 12
The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.
Month 12
ORR by IRF Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
ORR by IRF per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
ORR by Investigator Assessment Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
ORR by investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
CR Rate by IRF Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
CR rate by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was defined as the percentage of participants who achieved a CR by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease.
Up to approximately 7 months
CR Rate by Investigator Assessment Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
CR rate by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease
Up to approximately 7 months
Time to Response (TTR) by IRF Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
TTR by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by IRF following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification
Tidsramme: Up to approximately 7 months
TTR by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by investigator assessment following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
1-Year PFS Rate by IRF Per 2014 Lugano Classification
Tidsramme: Month 12
The 1-year PFS rate by IRF per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
1-Year PFS Rate by Investigator Assessment Per 2014 Lugano Classification
Tidsramme: Month 12
The 1-year PFS rate by investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
Duration of Response (DOR) by Investigator Assessment Per 2014 Lugano Classification
Tidsramme: Up to approximately 36 months
DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Up to approximately 36 months
Serum Antibody-Drug Conjugate (ADC) Concentration
Tidsramme: Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells.
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Plasma Monomethyl Auristatin E (MMAE) Concentration
Tidsramme: Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs.
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive
Tidsramme: Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
ADA Titer in Participants Positive for ADA Post Baseline
Tidsramme: Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb)
Tidsramme: Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Efterforskere

  • Studieleder: Medical Director, Takeda

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. februar 2023

Primær færdiggørelse (Faktiske)

27. april 2025

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

4. januar 2023

Først indsendt, der opfyldte QC-kriterier

4. januar 2023

Først opslået (Faktiske)

6. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C25024

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Takeda giver adgang til de afidentificerede individuelle deltagerdata (IPD) for kvalificerede undersøgelser for at hjælpe kvalificerede forskere med at løse legitime videnskabelige mål (Takedas tilsagn om datadeling er tilgængelig på https://clinicaltrials.takeda.com/takedas-commitment?commitment= 5). Disse IPD'er vil blive leveret i et sikkert forskningsmiljø efter godkendelse af en anmodning om datadeling og under betingelserne i en datadelingsaftale.

IPD-delingsadgangskriterier

IPD fra kvalificerede undersøgelser vil blive delt med kvalificerede forskere i henhold til kriterierne og processen beskrevet på https://vivli.org/ourmember/takeda/ For godkendte anmodninger vil forskerne få adgang til anonymiserede data (for at respektere patientens privatliv i overensstemmelse med gældende love og regler) og med oplysninger, der er nødvendige for at opfylde forskningsmålene i henhold til vilkårene i en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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