Relapsed/Refractory Peripheral T-Cell LymphomaPhase 2NCT04703192
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 study testing Valemetostat Tosylate in people with Relapsed/Refractory Peripheral T-Cell Lymphoma and Adult T Cell Leukemia/Lymphoma, run by Daiichi Sankyo at 60 sites in 12 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
- What is being tested?
- Valemetostat Tosylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 60 sitesin 12 countries
- Study dates
- 3 Jun 2021to 19 Jun 2029
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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.
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
60 sites in 12 countries.
60 sites in 12 countries
United States14 sites
Emory University Hospital - Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Colorado Cancer Center
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
City Of Hope National Medical Center
Duarte, California, 91010
Duke Cancer Center
Durham, North Carolina, 27710
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601
Memorial Sloan-Kettering Cancer Center at Memorial Hospital
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY
Palo Alto, California, 94304
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Rochester
Rochester, Minnesota, 55901
University of California San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Japan10 sites
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka, 812-0054
Kagoshima University Hospital
Kagoshima, 890-8520
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
University Hospital - Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Nagasaki University Hospital
Nagasaki, 852-8501
National Hospital Organization Nagoya Medical Center - Hematology
Nagoya, Aichi-ken, 460-0001
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Okayama University Hospital
Okayama, 700-8558
Hokkaido University Hospital - Medical Oncology Center
Sapporo, Hokkaido, 060-8648
France7 sites
CHU de Dijon
Dijon, 21079
CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang
Lille, 59037
Centre Lyon Berard - Medical Oncology
Lyon, 69008
APHP - Hopital Saint Louis
Paris, 75010
Hôpital Necker
Paris, 75015
Centre Hospitalier Lyon Sud - Hématologie
Pierre-Bénite, 69495
Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, 31100
Italy5 sites
ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo
Bergamo, 24127
A.O.di Bologna Policl.S.Orsola
Bologna, 40138
PO San Gerardo, ASST Monza
Monza, 20900
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
Naples, 80131
Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia
Perugia, 06132
South Korea5 sites
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
Seoul National University Hospital - Department of Internal
Seoul, 03080
Asan Medical Center - Oncology
Seoul, 05505
Samsung Medical Center - Hematology-Oncology
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Spain5 sites
ICO Hospital Duran i Reynals
Barcelona, 08029
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocio
Seville, 41013
Taiwan4 sites
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, 83301
National Cheng Kung University Hospital - Internal Medicine
Tainan, 70403
National Taiwan University Hospital - Hematology And Oncology
Taipei, 10002
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Taoyuan City, 33305
Canada3 sites
Ottawa Hospital Research Institute
Ottawa, K1H 8L6
University Health Network Princess Margaret Hospital
Toronto, M5G 1Z5
BC Cancer - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
United Kingdom3 sites
University College London Hospital
London, NW1 2PG
Nottingham City Hospital - Clinical Haematology
Nottingham, NG5 1PB
Churchill Hospital
Oxford, OX3 7LE
Netherlands2 sites
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
Leiden, 2333ZA
Universiteit Maastricht Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX
Germany1 site
Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV
Halle, 06120
About this study
Official title: Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (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.
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.
- Being tested
- Valemetostat Tosylate
- Keywords
- Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T-Cell Leukemia/Lymphoma, Valemetostat Tosylate, DS-3201b
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valemetostat TosylateDrug
Also called DS-3201b
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma | Experimental | 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. Receives: Drug: Valemetostat Tosylate |
| Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | Experimental | 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. Receives: Drug: Valemetostat Tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From the time the informed consent form is signed up to 30 days after last dose, up to 23 months
Secondary outcomes (6)
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.
Measured: 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)
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.
Measured: 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)
Complete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments.
Measured: 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)
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.
Measured: 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)
Partial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment.
Measured: From baseline to date of first documented objective response of PR, up to approximately 56 months
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Measured: From the time the informed consent form is signed up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start3 Jun 2021
- Primary completion10 May 2023
- Study completion19 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703192
- Sponsor's protocol ID
- DS3201-A-U202
- Other IDs
- 2020-004954-31, jRCT2071200095, 2023-507381-13-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2021
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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/
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 at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
- ClinicalTrials.gov ID
- NCT04703192
- Acronym / sponsor ID
- DS3201-A-U202
- Keywords
- Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T-Cell Leukemia/Lymphoma, Valemetostat Tosylate, DS-3201b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 19 Jun 2029 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 22 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma | Experimental | Drug: Valemetostat TosylateParticipants 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. |
| Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | Experimental | Drug: Valemetostat TosylateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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):
- 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.
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valemetostat TosylateAlso: DS-3201bOral 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 | Drug | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma, Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma |
Primary outcome
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Time frame: 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.
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
Time frame: 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.
6 secondary outcomes
Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy
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)
Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
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
Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Time frame: 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)
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
Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Time frame: From baseline to date of first documented objective response of PR, up to approximately 56 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39486433Zinzani 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.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
60 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valemetostat Tosylate in people with Relapsed/Refractory Peripheral T-Cell Lymphoma and Adult T Cell Leukemia/Lymphoma, run by Daiichi Sankyo at 60 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Japan, France, Italy, South Korea and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) (time frame: From baseline until disease progression or death (whichever occurs first), up to approximately 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.