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Soquelitinib vs Standard of Care hos deltagere med recidiverende/refraktært perifert T-celle lymfom ikke andet specificeret, follikulært hjælper T-celle lymfom eller systemisk anaplastisk storcellet lymfom

22. september 2026 opdateret af: Corvus Pharmaceuticals, Inc.

Et fase 3, randomiseret, åbent-label-studie for at undersøge effektiviteten og sikkerheden af ​​ITK-hæmmer Soquelitinib versus lægens valg standardbehandling (udvalgt enkeltstof) hos deltagere med recidiverende/refraktært perifert T-cellelymfom ikke andet specificeret, follikulær hjælper T -celle lymfomer eller systemisk anaplastisk storcellet lymfom

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, versus physician's choice standard of care (SOC) treatment of either belinostat or pralatrexate in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL). Approximately 150 participants will be randomized at a 1:1 ratio to the 2 treatment arms (soquelitinib or SOC) and will be stratified by region of the world, age, and time to relapse for the most recent prior therapy. Participants will receive study treatment for up to a maximum of 2 years, unacceptable toxicity, or disease progression, whichever is earlier. Participants randomized to receive SOC who have confirmation of progressive disease may have the opportunity to crossover to receive treatment with soquelitinib.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
    • Queensland
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Royal Adelaide Hospital
        • Ledende efterforsker:
          • Pratyush Giri
        • Kontakt:
      • Bedford Park, South Australia, Australien, 5042
        • Rekruttering
        • Flinders Medical Center
        • Ledende efterforsker:
          • Kate Manos
        • Kontakt:
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Rekruttering
        • Box Hill Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Tamara Marconi
      • Heidelberg, Victoria, Australien, 3084
        • Rekruttering
        • Austin Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Eliza Hawkes
      • Richmond, Victoria, Australien, 3121
    • Western Australia
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • Rekruttering
        • BC Cancer Research Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Rekruttering
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5G2C4
        • Rekruttering
        • The Princess Margaret Cancer Centre
        • Ledende efterforsker:
          • Anca Prica
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope National Medical Center
        • Ledende efterforsker:
          • Christina Poh, MD
        • Kontakt:
          • Christina Poh, MD
          • Telefonnummer: 626-713-7102
          • E-mail: cpoh@coh.org
      • Irvine, California, Forenede Stater, 92697
        • Rekruttering
        • University of California, Irvine
        • Kontakt:
      • San Francisco, California, Forenede Stater, 94143
        • Rekruttering
        • University of California San Francisco
        • Kontakt:
        • Ledende efterforsker:
          • Weiyun Ai, MD
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Rekruttering
        • Yale University
        • Kontakt:
        • Ledende efterforsker:
          • Francine Foss, MD
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
        • Kontakt:
          • Telefonnummer: 305-242-5302
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
        • Ledende efterforsker:
          • Jonathan Moreira, MD
        • Kontakt:
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Rekruttering
        • University of Iowa
        • Ledende efterforsker:
          • Eric Mou, MD
        • Kontakt:
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Rekruttering
        • University of Maryland Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Kathryn Kline, MD
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Ledende efterforsker:
          • Salvia Jain, MD
        • Kontakt:
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • Roger Cancer Center University of Michigan Health
        • Ledende efterforsker:
          • Ryan Wilcox, MD
        • Kontakt:
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63130
        • Rekruttering
        • Washington University in St. Louis
        • Ledende efterforsker:
          • Neha Mehta-Shah, MD
        • Kontakt:
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Rekruttering
        • Hackensack University Medical Center
        • Ledende efterforsker:
          • Tatyana Feldman, MD
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Weill Cornell Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Jia Ruan, MD, PHD
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Ledende efterforsker:
          • Jasmine Zain, MD
        • Kontakt:
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Ledende efterforsker:
          • Roshan Asrani, MD
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Rekruttering
        • North Carolina Cancer Hospital
        • Ledende efterforsker:
          • Anne Beaven, MD
        • Kontakt:
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University
        • Kontakt:
        • Ledende efterforsker:
          • John Reneau, MD, PHD
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Rekruttering
        • Oregon Health & Science University; Knight Cancer Institute
        • Kontakt:
          • Clinical Trials Office
          • Telefonnummer: 503-494-1080
          • E-mail: trials@ohsu.edu
        • Ledende efterforsker:
          • Dr. Craig Okada, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Rekruttering
        • University of Pittsburgh Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Oleg Akilov, MD, PHD
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Rekruttering
        • UT Southwestern Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Elif Yilmaz, MD
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Ledende efterforsker:
          • Swaminathan Iyer, MD
        • Kontakt:
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Rekruttering
        • University of Washington Fred Hutch Cancer Center
        • Ledende efterforsker:
          • Stephen Smith, MD
        • Kontakt:
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Rekruttering
        • University of Wisconsin Carbone Cancer Center
        • Kontakt:

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult participants ≥18 years of age on the day of signing the informed consent form.

  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

  3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.

  4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.

  5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.

  6. Life expectancy >12 weeks.

  7. Adequate organ function as determined by:

    • Absolute neutrophil count ≥ 1.0×10^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
    • Platelet count ≥ 100×10^9/L (without transfusion)
    • Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
    • Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
    • Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
    • Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor
    • Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
    • Serum albumin > 2.5 g/dL
    • Serum calcium < 12 mg/dL or corrected serum calcium < ULN

  8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:

    • Grade ≤ 2 neuropathy
    • Alopecia and non-acute toxicities
    • If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment

  9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.

  10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.

Exclusion Criteria:

  1. Participants who have T-cell lymphoma with active central nervous system involvement.
  2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  3. History of primary immunodeficiency or sold organ transplantation.
  4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
  5. Any active infection requiring IV therapy.
  6. History of invasive prior malignancy that required systemic therapy within last 3 years.
  7. Any condition that confounds the ability to interpret data from the study.
  8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg]) or positive test for hepatitis C antibody.
  9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.
  10. Prior administration of an ITK inhibitor.
  11. Participants who need immediate cytoreductive therapy.
  12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.
  13. History of allogeneic hematopoietic stem cell transplantation.
  14. Candidate for hematopoietic stem cell transplantation at screening.
  15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
  16. Concurrent enrollment in another clinical study
  17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.
  18. Participants who cannot ingest medications orally or who have malabsorption.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Soquelitinib

Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years
Medicin: Soquelitinib

Soquelitinib 200 mg tablets will be taken by mouth two times a day

Andre navne:
  • CPI-818
Aktiv komparator: Standard of Care

Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years
Medicin: Belinostat

Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle

Andre navne:
  • Beleodaq®
Medicin: Pralatrexate

Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle

Andre navne:
  • Folotyn®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: Up to 4 years post study treatment initiation

Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
Up to 4 years post study treatment initiation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate
Tidsramme: Up to 2 years post study treatment initiation

The rate of participants who achieve a partial response or complete response as assessed by the Independent Review Committee according to the Revised Criteria for Response Assessment of Malignant Lymphoma (Lugano Classification 2014), and modified Severity Weighted Assessment Tool (mSWAT) for participants with skin involvement
Up to 2 years post study treatment initiation
Overall survival
Tidsramme: Up to 4 years post study treatment initiation

Time from first study treatment to death from any cause
Up to 4 years post study treatment initiation

Samarbejdspartnere og efterforskere

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

Sponsor

Corvus Pharmaceuticals, Inc.

Efterforskere

  • Studieleder: Suresh Mahabhashyam, MD, MPH, Corvus Pharmaceuticals, Inc.

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)

2. oktober 2024

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

16. august 2024

Først indsendt, der opfyldte QC-kriterier

16. august 2024

Først opslået (Faktiske)

19. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CPI-818-004

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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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