At a glance
ClinicalIndex Comparison RecordPhase 2Active· 155 enrolled
Drug / intervention
Valemetostat Tosylatedrug
Likely dose
Valemetostat Tosylate 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
In Brief
A Phase 2 clinical trial evaluating Valemetostat Tosylate for Relapsed/Refractory Peripheral T-Cell Lymphoma and Adult T Cell Leukemia/Lymphoma. Active but no longer recruiting, targeting 155 participants across 60 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2Active
2021202220232024202520262027
First PostedJan 2021
Enrollment StartJun 2021
Primary CompletionMay 2023
TodayJul 2026
Study CompletionFeb 2027
First PostedJan 11, 2021
Enrollment StartJun 3, 2021
Primary CompletionMay 10, 2023
Study CompletionFeb 19, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.5 years ago
Interventions
Valemetostat Tosylatedrug
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