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

Running, not enrolling · Phase 2

Conditions studied: Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma

In brief

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.

Key facts

Study ID: NCT04703192
Run by: Daiichi Sankyo
People needed: 155
Starts: 2021-06-03
Expected to finish: 2027-08-31
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY — Palo Alto, California, United States
University of California San Francisco — San Francisco, California, United States
University Of Colorado Cancer Center — Aurora, Colorado, United States
Emory University Hospital - Winship Cancer Institute — Atlanta, Georgia, United States
Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic - Rochester — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Memorial Hospital — New York, New York, United States
Weill Cornell Medicine — New York, New York, United States
Duke Cancer Center — Durham, North Carolina, United States
University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
Epworth Healthcare — Richmond, Australia
BC Cancer - Vancouver Centre — Vancouver, British Columbia, Canada
Ottawa Hospital Research Institute — Ottawa, Canada
University Health Network Princess Margaret Hospital — Toronto, Canada
CHU de Dijon — Dijon, France
CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang — Lille, France
Centre Lyon Berard - Medical Oncology — Lyon, France
APHP - Hopital Saint Louis — Paris, France
Hôpital Necker — Paris, France
Centre Hospitalier Lyon Sud - Hématologie — Pierre-Bénite, France
Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) — Toulouse, France
City Of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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