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Active, not recruitingNCT04703192Updated Jul 20, 2026Results posted

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

A Phase 2 interventional study of Valemetostat Tosylate in Relapsed/Refractory Peripheral T-Cell Lymphoma and Adult T Cell Leukemia/Lymphoma, sponsored by Daiichi Sankyo. Active, not recruiting at 60 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Daiichi Sankyo · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Relapsed/Refractory Peripheral T-Cell Lymphoma
  • Adult T Cell Leukemia/Lymphoma

Keywords

  • Relapsed/Refractory Peripheral T-Cell Lymphoma
  • Adult T-Cell Leukemia/Lymphoma
  • Valemetostat Tosylate
  • DS-3201b
03

In context

Lymphoma, T-Cell, Peripheral

604 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.

This study's enrollment of 155 is above the median of 38 across 527 interventional studies indexed under Lymphoma, T-Cell, Peripheral.

Browse Lymphoma, T-Cell, Peripheral studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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, ALK positive
      • Anaplastic large cell lymphoma, 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 CR (or CRu for ATL) after first-line therapy
      • Failure to reach at least 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 anaplastic large cell lymphoma (ALCL) must have prior brentuximab vedotin treatment.

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Valemetostat Tosylate

  • Experimental
    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.

    Drug: Valemetostat Tosylate

Interventions

  • DrugValemetostat 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

    Also known as: DS-3201b

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    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.

    Time frame: From baseline until disease progression or death (whichever occurs first), up to approximately 23 months

  2. Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)

    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.

    Time frame: From the time the informed consent form is signed up to 30 days after last dose, up to 23 months

Secondary outcomes

  1. Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy

    Total and unbound DS-3201a (free form of valemetostat tosylate) and total CALZ-1809a (major metabolite) concentration in plasma will be assessed.

    Time frame: 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)

  2. Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    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 frame: 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

  3. Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    Complete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments.

    Time frame: From baseline to date of first documented objective response of CR, up to approximately 56 months

  4. Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    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 frame: 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

  5. Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    Partial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment.

    Time frame: From baseline to date of first documented objective response of PR, up to approximately 56 months

  6. Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

    Time frame: From the time the informed consent form is signed up to 30 days after last dose

07

Results

Posted Jul 22, 2024

Participant flow

A total of 155 participants who met all inclusion criteria and no exclusion criteria were enrolled to receive valemetostat tosylate treatment in 70 study sites in North America, Europe, Asia, and Oceania.

Participant flow — Overall Study
MilestoneCohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL)
Started13322
Completed322
Not completed10120
Withdrew: Withdrawal by subject20
Withdrew: Death31
Withdrew: Adverse event132
Withdrew: Progressive or relapsed disease467
Withdrew: Clinical progression198
Withdrew: Lost to follow-up10
Withdrew: Hematopoietic cell transplantation121
Withdrew: Other51

Outcome measures

PrimaryPercentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

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.

Time frame:
From baseline until disease progression or death (whichever occurs first), up to approximately 23 months
Reported as:
Number · percentage of participants
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
percentage of participantsCohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)43.7 (34.6 to 53.1)
PrimaryNumber of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)

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.

Time frame:
From the time the informed consent form is signed up to 30 days after last dose, up to 23 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
ParticipantsCohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)22
SecondaryPlasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy

Total and unbound DS-3201a (free form of valemetostat tosylate) and total CALZ-1809a (major metabolite) concentration in plasma will be assessed.

Time frame:
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)

Results for this outcome have not been posted.

SecondaryDuration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

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 frame:
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

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

Complete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments.

Time frame:
From baseline to date of first documented objective response of CR, up to approximately 56 months

Results for this outcome have not been posted.

SecondaryDuration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

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 frame:
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

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

Partial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment.

Time frame:
From baseline to date of first documented objective response of PR, up to approximately 56 months

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Time frame:
From the time the informed consent form is signed up to 30 days after last dose

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months. Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)52/133 (39.1%)53/133 (39.8%)120/133 (90.2%)
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma16/22 (72.7%)15/22 (68.2%)22/22 (100%)
Most frequent serious events
Showing 10 of 87
Most frequent serious events
EventCohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
Disease progressionGeneral disorders7/1333/22
DiarrhoeaGastrointestinal disorders2/1332/22
COVID-19Infections and infestations2/1332/22
ThrombocytopeniaBlood and lymphatic system disorders1/1331/22
Coombs negative haemolytic anaemiaBlood and lymphatic system disorders0/1331/22
Intestinal perforationGastrointestinal disorders1/1331/22
ColitisGastrointestinal disorders0/1331/22
Gastric haemorrhageGastrointestinal disorders0/1331/22
Upper gastrointestinal haemorrhageGastrointestinal disorders0/1331/22
VomitingGastrointestinal disorders0/1331/22
Most frequent other events
Showing 10 of 49
Most frequent other events
EventCohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
AnaemiaBlood and lymphatic system disorders47/13311/22
Platelet count decreasedInvestigations31/1339/22
DiarrhoeaGastrointestinal disorders38/1335/22
DysgeusiaNervous system disorders38/1335/22
Neutrophil count decreasedInvestigations18/1336/22
HypercalcaemiaMetabolism and nutrition disorders2/1336/22
ThrombocytopeniaBlood and lymphatic system disorders35/1334/22
COVID-19Infections and infestations27/1334/22
NauseaGastrointestinal disorders23/1334/22
White blood cell count decreasedInvestigations7/1334/22

Baseline characteristics

The Safety Analysis Set included all subjects who received at least 1 dose of study drug. Subjects were analyzed for each cohort.

Age, Categorical
Age, Categorical(Participants)Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaTotal
<=18 years000
Between 18 and 65 years531063
>=65 years801292
Age, Continuous
Age, Continuous(years)Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaTotal
Mean65.6 ± 12.5162.6 ± 13.1165.2 ± 12.60
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaTotal
Female42749
Male9115106
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaTotal
American Indian or Alaska Native101
Asian34842
Native Hawaiian or Other Pacific Islander000
Black or African American61016
White80181
More than one race000
Unknown or Not Reported12315
08

Study locations

60 sites
  • City Of Hope National Medical Center
    Duarte, California 91010, United States
  • Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY
    Palo Alto, California 94304, United States
  • University of California San Francisco
    San Francisco, California 94143, United States
  • University Of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • Emory University Hospital - Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Northwestern University - Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55901, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Hackensack University Medical Center - John Theurer Cancer Center
    Hackensack, New Jersey 07601, United States
  • Memorial Sloan-Kettering Cancer Center at Memorial Hospital
    New York, New York 10065, United States
  • Weill Cornell Medicine
    New York, New York 10065, United States
  • Duke Cancer Center
    Durham, North Carolina 27710, United States
  • University of Pennsylvania Perelman Center for Advanced Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Epworth Healthcare
    Richmond, 3121, Australia
  • BC Cancer - Vancouver Centre
    Vancouver, British Columbia V5Z 4E6, Canada
  • Ottawa Hospital Research Institute
    Ottawa, K1H 8L6, Canada
  • University Health Network Princess Margaret Hospital
    Toronto, M5G 1Z5, Canada
  • CHU de Dijon
    Dijon, 21079, France
  • CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang
    Lille, 59037, France
  • Centre Lyon Berard - Medical Oncology
    Lyon, 69008, France
  • APHP - Hopital Saint Louis
    Paris, 75010, France
  • Hôpital Necker
    Paris, 75015, France
  • Centre Hospitalier Lyon Sud - Hématologie
    Pierre-Bénite, 69495, France
  • Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
    Toulouse, 31100, France
  • Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV
    Halle, 06120, Germany
  • ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
    Bergamo, 24127, Italy
  • A.O.di Bologna Policl.S.Orsola
    Bologna, 40138, Italy
  • PO San Gerardo, ASST Monza
    Monza, 20900, Italy
  • Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
    Naples, 80131, Italy
  • Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia
    Perugia, 06132, Italy
  • National Hospital Organization Nagoya Medical Center - Hematology
    Nagoya, Aichi-ken 460-0001, Japan
  • Nagoya City University Hospital
    Nagoya, Aichi-ken 467-8602, Japan
  • National Cancer Center Hospital East
    Kashiwa, Chiba 277-8577, Japan
  • Hokkaido University Hospital - Medical Oncology Center
    Sapporo, Hokkaido 060-8648, Japan
  • National Cancer Center Hospital
    Chuo Ku, Tokyo 104-0045, Japan
  • Kyushu University Hospital
    Fukuoka, 812-0054, Japan
  • Kagoshima University Hospital
    Kagoshima, 890-8520, Japan
  • University Hospital - Kyoto Prefectural University of Medicine
    Kyoto, 602-8566, Japan
  • Nagasaki University Hospital
    Nagasaki, 852-8501, Japan
  • Okayama University Hospital
    Okayama, 700-8558, Japan
  • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
    Leiden, 2333ZA, Netherlands
  • Universiteit Maastricht Academisch Ziekenhuis Maastricht
    Maastricht, 6229 HX, Netherlands
  • Severance Hospital, Yonsei University Health System
    Seoul, Seoul Teugbyeolsi 03722, South Korea
  • Seoul National University Hospital - Department of Internal
    Seoul, 03080, South Korea
  • Asan Medical Center - Oncology
    Seoul, 05505, South Korea
  • Samsung Medical Center - Hematology-Oncology
    Seoul, 06351, South Korea
  • The Catholic University of Korea, Seoul St. Mary's Hospital
    Seoul, 06591, South Korea
  • ICO Hospital Duran i Reynals
    Barcelona, 08029, Spain
  • Hospital Universitario Vall d'Hebrón
    Barcelona, 08035, Spain
  • Hospital Universitario Fundación Jiménez Díaz
    Madrid, 28040, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Hospital Universitario Virgen del Rocio
    Seville, 41013, Spain
  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
    Kaohsiung City, 83301, Taiwan
  • National Cheng Kung University Hospital - Internal Medicine
    Tainan, 70403, Taiwan
  • National Taiwan University Hospital - Hematology And Oncology
    Taipei, 10002, Taiwan
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
    Taoyuan City, 33305, Taiwan
  • University College London Hospital
    London, NW1 2PG, United Kingdom
  • Nottingham City Hospital - Clinical Haematology
    Nottingham, NG5 1PB, United Kingdom
  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
09

References and documents

Publications

  • Zinzani PL, Izutsu K, Mehta-Shah N, Barta SK, Ishitsuka K, Cordoba R, Kusumoto S, Bachy E, Cwynarski K, Gritti G, Prica A, Jacobsen E, Feldman T, Guillermin Y, Ennishi D, Yoon DH, Domenech ED, Zain J, Wang J, Kim JS, Poel MV, Jin J, Wu S, Chen Y, Moriyama T, Inoue A, Nakajima K, Horwitz SM. Valemetostat for patients with relapsed or refractory peripheral T-cell lymphoma (VALENTINE-PTCL01): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2024 Dec;25(12):1602-1613. doi: 10.1016/S1470-2045(24)00503-5. Epub 2024 Oct 29. PubMed 39486433 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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/

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04703192
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Jan 11, 2021
Start date
Jun 3, 2021
Primary completion
May 10, 2023
Completion
Aug 31, 2027 (estimated)
Results posted
Jul 22, 2024
Last update
Jul 20, 2026

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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