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Valemetostat Tosylate (DS-3201b), en forsterker av Zeste Homolog (EZH) 1/2 Dual Inhibitor, for residiverende/ildfast perifert T-celle lymfom (VALENTINE-PTCL01)

23. oktober 2026 oppdatert av: Daiichi Sankyo

Enarms, fase 2-studie av Valemetostat Tosylate Monoterapi hos personer med residiverende/refraktært perifert T-celle lymfom (VALENTINE-PTCL01)

This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study was designed to evaluate the efficacy and safety of valemetostat tosylate monotherapy. The primary objective will evaluate objective response rate of valemetostat tosylate monotherapy as measured by blinded independent central review (BICR) in relapsed/refractory peripheral T-cell lymphoma.

Studietype

Intervensjonell

Registrering (Faktiske)

155

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Richmond, Australia, 3121
        • Epworth Healthcare
  • Canada
      • Ottawa, Canada, K1H 8L6
        • Ottawa Hospital Research Institute
      • Toronto, Canada, M5G 1Z5
        • University Health Network Princess Margaret Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver Centre
  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • City Of Hope National Medical Center
      • Palo Alto, California, Forente stater, 94304
        • Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY
      • San Francisco, California, Forente stater, 94143
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University Of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital - Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University - Feinberg School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55901
        • Mayo Clinic - Rochester
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center - John Theurer Cancer Center
    • New York
      • New York, New York, Forente stater, 10065
        • Weill Cornell Medicine
      • New York, New York, Forente stater, 10065
        • Memorial Sloan-Kettering Cancer Center at Memorial Hospital
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania Perelman Center for Advanced Medicine
  • Frankrike
      • Dijon, Frankrike, 21079
        • CHU de Dijon
      • Lille, Frankrike, 59037
        • CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang
      • Lyon, Frankrike, 69008
        • Centre Lyon Berard - Medical Oncology
      • Paris, Frankrike, 75010
        • APHP - Hopital Saint Louis
      • Paris, Frankrike, 75015
        • Hôpital Necker
      • Pierre-Bénite, Frankrike, 69495
        • Centre Hospitalier Lyon Sud - Hématologie
      • Toulouse, Frankrike, 31100
        • Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
  • Italia
      • Bergamo, Italia, 24127
        • ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
      • Bologna, Italia, 40138
        • A.O.di Bologna Policl.S.Orsola
      • Monza, Italia, 20900
        • PO San Gerardo, ASST Monza
      • Naples, Italia, 80131
        • Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
      • Perugia, Italia, 06132
        • Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia
  • Japan
      • Fukuoka, Japan, 812-0054
        • Kyushu University Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital - Kyoto Prefectural University of Medicine
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi-ken, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center - Hematology
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital - Medical Oncology Center
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Nederland
      • Leiden, Nederland, 2333ZA
        • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
      • Maastricht, Nederland, 6229 HX
        • Universiteit Maastricht Academisch Ziekenhuis Maastricht
  • Spania
      • Barcelona, Spania, 08029
        • ICO Hospital Duran i Reynals
      • Barcelona, Spania, 08035
        • Hospital Universitario Vall d'Hebrón
      • Madrid, Spania, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
      • Seville, Spania, 41013
        • Hospital Universitario Virgen del Rocio
  • Storbritannia
      • London, Storbritannia, NW1 2PG
        • University College London Hospital
      • Nottingham, Storbritannia, NG5 1PB
        • Nottingham City Hospital - Clinical Haematology
      • Oxford, Storbritannia, OX3 7LE
        • Churchill Hospital
  • Sør -Korea
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital - Department of Internal
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center - Oncology
      • Seoul, Sør -Korea, 06351
        • Samsung Medical Center - Hematology-Oncology
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital - Internal Medicine
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital - Hematology And Oncology
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
  • Tyskland
      • Halle, Tyskland, 06120
        • Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent

  • Participants ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.

  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2

  • Cohort 1 relapsed/refractory peripheral T-cell lymphoma (PTCL):

    • Diagnosis should be confirmed by the local pathologist; local histological diagnosis will be used for eligibility determination. Participants with the following subtypes of PTCL are eligible according to 2016 WHO classification prior to the initiation of study drug. Any T-cell lymphoid malignancies not listed are excluded. Eligible subtypes include:

      • Enteropathy-associated T-cell lymphoma
      • Monomorphic epitheliotropic intestinal T-cell lymphoma
      • Hepatosplenic T-cell lymphoma
      • Primary cutaneous γδ T-cell lymphoma
      • Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
      • PTCL, not otherwise specified
      • Angioimmunoblastic T-cell lymphoma
      • Follicular T-cell lymphoma
      • Nodal PTCL with T-follicular helper (TFH) phenotype
      • Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase (ALK) positive
      • ALCL, ALK negative

  • Cohort 2 relapsed/refractory adult T-cell leukemia/lymphoma (ATL) acute, lymphoma, or unfavorable chronic type. Relapsed/refractory ATL should be confirmed by the local pathologist; local diagnosis will be used for eligibility determination. The positivity of anti-human T-cell leukemia virus type 1 (HTLV-1) antibody will be locally determined for eligibility.

  • Must have at least one lesion which is measurable in 2 perpendicular dimensions on computed tomography (or magnetic resonance imaging) based on local radiological read

  • Documented refractory, relapsed, or progressive disease after at least 1 prior line of systemic therapy.

    • Refractory is defined as:

      • Failure to achieve complete response (CR) (or uncertified CR [CRu] for ATL) after first-line therapy
      • Failure to reach at least partial response (PR) after second-line therapy or beyond

  • Must have at least 1 prior line of systemic therapy for PTCL or ATL.

    • Participants must be considered hematopoietic cell transplantation (HCT) ineligible during screening due to disease status (active disease), comorbidities, or other factors; the reason for HCT ineligibility must be clearly documented.
    • In the PTCL cohort, participants with ALCL must have prior brentuximab vedotin treatment.

Exclusion Criteria:

Participants meeting any exclusion criteria for this study will be excluded from this study. Below is a list of the key exclusion criteria:

  • Diagnosis of mycosis fungoides, Sézary syndrome and primary cutaneous ALCL, and systemic dissemination of primary cutaneous ALCL

  • Diagnosis of precursor T-cell leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia

  • Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer.

  • Presence of active central nervous system involvement of lymphoma

  • History of autologous HCT within 60 days prior to the first dose of study drug

  • History of allogeneic HCT within 90 days prior to the first dose of study drug

  • Clinically significant graft-versus-host disease (GVHD) or GVHD requiring systemic immunosuppressive prophylaxis or treatment

  • Inadequate washout period from prior lymphoma-directed therapy before enrollment, defined as follows:

    • Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks prior or 5 half-lives of the drug, whichever is longer, to the first dose of study drug
    • Had curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug

  • Uncontrolled or significant cardiovascular disease, including:

    • Evidence of prolongation of QT/QTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method >450 ms) (average of triplicate determinations)
    • Diagnosed or suspected long QT syndrome or known family history of long QT syndrome
    • History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
    • Uncontrolled arrhythmia (subjects with asymptomatic, controllable atrial fibrillation may be enrolled) or asymptomatic persistent ventricular tachycardia
    • Participant has clinically relevant bradycardia of <50 bpm, unless the participant has a pacemaker
    • History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers within 6 months prior to Screening
    • Myocardial infarction within 6 months prior to Screening
    • Angioplasty or stent craft implantation within 6 months prior to Screening
    • Uncontrolled angina pectoris within 6 months prior to Screening
    • New York Heart Association Class 3 or 4 congestive heart failure
    • Coronary/peripheral artery bypass graft within 6 months prior to Screening
    • Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
    • Complete left bundle branch block

  • History of treatment with other EZH inhibitors

  • Current use of moderate or strong cytochrome P450 (CYP)3A inducers

  • Systemic treatment with corticosteroids (>10 mg daily prednisone equivalents). Note: Short-course systemic corticosteroids (eg, prevention/treatment for transfusion reaction) or use for a non-cancer indication (eg, adrenal replacement) is permissible.

  • Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma

Participants who will receive 200 mg/day valemetostat tosylate and had an eligible peripheral T-cell lymphoma subtype that was confirmed by independent hematopathology central review.
Legemiddel: Valemetostat Tosylate

Oral administration of valemetostat tosylate at a dose of 200 mg once daily starting at Cycle 1, Day 1 (continuous for 28-day cycles), until disease progression or unacceptable toxicity

Andre navn:
  • DS-3201b
Eksperimentell: Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma

Participants who will receive 200 mg/day valemetostat tosylate and had an eligible adult T-cell leukemia/lymphoma subtype that was confirmed by the local pathologist/investigators and by documented positive anti-human T-cell leukemia virus type 1 (HTLV-1) antibody.
Legemiddel: Valemetostat Tosylate

Oral administration of valemetostat tosylate at a dose of 200 mg once daily starting at Cycle 1, Day 1 (continuous for 28-day cycles), until disease progression or unacceptable toxicity

Andre navn:
  • DS-3201b

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Tidsramme: From baseline until disease progression or death (whichever occurs first), up to approximately 23 months

For the relapsed/refractory peripheral T-cell lymphoma (PTCL) cohort, objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), assessed by blinded independent central review (BICR), among participants with centrally confirmed PTCL eligible histology.
From baseline until disease progression or death (whichever occurs first), up to approximately 23 months
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
Tidsramme: From the time the informed consent form is signed up to 30 days after last dose, up to 23 months

Treatment-emergent adverse events (TEAEs) were defined as new AEs or pre-existing conditions that worsen in National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade after the first dose of study drug and up to 30 days after the last dose of study drug.
From the time the informed consent form is signed up to 30 days after last dose, up to 23 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med behandlingsfremkomne bivirkninger etter administrering av Valemetostat Tosylate Monoterapi (Kohort 1)
Tidsramme: Fra tidspunktet skjemaet for informert samtykke er signert inntil 30 dager etter siste dose
Fra tidspunktet skjemaet for informert samtykke er signert inntil 30 dager etter siste dose
Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy
Tidsramme: Cycle 1 Day 1, 8, 15 Predose; Cycle 1 Day 1 (1, 2, 4, 5 hours Postdose); Cycle 2 Day 1 Predose; Cycle 3 Day 1 to Cycle 5 Day 1 Predose (each cycle is 28 days)

Total and unbound DS-3201a (free form of valemetostat tosylate) and total CALZ-1809a (major metabolite) concentration in plasma will be assessed.
Cycle 1 Day 1, 8, 15 Predose; Cycle 1 Day 1 (1, 2, 4, 5 hours Postdose); Cycle 2 Day 1 Predose; Cycle 3 Day 1 to Cycle 5 Day 1 Predose (each cycle is 28 days)
Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Tidsramme: Time from the date of first documented response (CR or PR) until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months

Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first.
Time from the date of first documented response (CR or PR) until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months
Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Tidsramme: From baseline to date of first documented objective response of CR, up to approximately 56 months

Complete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments.
From baseline to date of first documented objective response of CR, up to approximately 56 months
Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Tidsramme: Time from the date of first documented CR until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months

Duration of complete response is defined as the time from the date of the first documentation of CR to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first.
Time from the date of first documented CR until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months
Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Tidsramme: From baseline to date of first documented objective response of PR, up to approximately 56 months

Partial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment.
From baseline to date of first documented objective response of PR, up to approximately 56 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Daiichi Sankyo

Etterforskere

  • Studieleder: Global Clinical Leader, Daiichi Sankyo

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. juni 2021

Primær fullføring (Faktiske)

10. mai 2023

Studiet fullført (Antatt)

19. juni 2029

Datoer for studieregistrering

Først innsendt

7. januar 2021

Først innsendt som oppfylte QC-kriteriene

7. januar 2021

Først lagt ut (Faktiske)

11. januar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DS3201-A-U202
  • 2020-004954-31 (EudraCT-nummer)
  • 2023 (U.S. NIH-stipend/kontrakt)
  • jRCT2071200095 (Annen identifikator: jRCT)
  • 2023-507381-13-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD-delingstidsramme

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Tilgangskriterier for IPD-deling

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere