This Phase II trial is evaluating how safe and effective a new targeted therapy (valemetostat tosylate) is in patients with relapsed or refractory peripheral T-cell lymphoma, including adult T-cell leukaemia/lymphoma patients.
This trial is treating patients with relapsed or refractory peripheral T-cell lymphoma and adult T-cell leukaemia or lymphoma.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Commercial Sponsor
Daiichi Sankyo Ltd.
Summary
This is a non-randomised, parallel assignment trial with two cohorts. Cohort One will will consist of participants with an eligible relapsed/refractory peripheral T-cell lymphoma subtype. Cohort Two will consist of participants with an eligible adult T-cell leukaemia/lymphoma subtype. All participants will receive valemetostat tosylate, orally, at a dose of 200mg once daily starting at Cycle 1, Day 1 (continuous for 28-day cycles) until disease progression or unacceptable toxicity.
Recruiting Hospitals Read More