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EZH 1/2 Dual Inhibitor

Valemetostat for T-Cell Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to date of first documented objective response of pr, up to approximately 56 months
Awards & highlights

Study Summary

This trial will study how well valemetostat tosylate works in people with relapsed or refractory peripheral T-cell lymphoma, including adult T-cell leukemia/lymphoma.

Who is the study for?
Adults over 18 with relapsed/refractory peripheral T-cell lymphoma or adult T-cell leukemia/lymphoma, who have tried at least one systemic therapy and are ineligible for hematopoietic cell transplantation. Participants must have measurable disease and cannot have had recent major surgery or radiation, uncontrolled heart issues, prior EZH inhibitor treatment, certain other cancers within the last two years, active central nervous system involvement of lymphoma, or recent history of stem cell transplant.Check my eligibility
What is being tested?
The trial is testing Valemetostat Tosylate's safety and effectiveness in patients with specific types of peripheral T-cell lymphomas that haven't responded to previous treatments. It focuses on those whose conditions returned after treatment or didn't improve significantly.See study design
What are the potential side effects?
While not explicitly listed in the provided information, side effects may include typical reactions to cancer therapies such as fatigue, nausea, blood count changes leading to increased infection risk or bleeding tendencies. Specific side effects related to Valemetostat Tosylate will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured in size using a CT or MRI scan.
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I have a tumor that can be measured in size using a CT or MRI scan.
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My condition is ALK-negative anaplastic large cell lymphoma.
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I have a specific type of leukemia/lymphoma that has not responded to treatment.
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I have had at least one treatment for my lymphoma.
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My leukemia/lymphoma has returned or didn't respond to treatment, and I tested positive for HTLV-1.
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My cancer did not fully respond to the first or second-line treatments.
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My T-cell lymphoma diagnosis matches the eligible types listed by WHO.
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I have ALCL and have been treated with brentuximab vedotin.
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My lymphoma is ALK positive.
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I have a specific type of T-cell lymphoma confirmed by a pathologist.
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My lymphoma is of the T-follicular helper type.
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I am not eligible for a stem cell transplant due to my health condition or other reasons.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take care of myself and am up and about more than half of my waking hours.
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My condition is enteropathy-associated T-cell lymphoma.
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I have been diagnosed with a specific type of intestinal lymphoma.
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I have been diagnosed with hepatosplenic T-cell lymphoma.
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I have been diagnosed with a type of skin lymphoma called γδ T-cell.
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I have been diagnosed with a specific type of skin lymphoma.
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My condition is PTCL, not otherwise specified.
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I have been diagnosed with angioimmunoblastic T-cell lymphoma.
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My condition worsened or did not improve after at least one treatment.
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My first cancer treatment did not fully clear the cancer.
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My cancer did not improve significantly after my second or later treatment.
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I have had at least one treatment for my T-cell lymphoma.
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I am not eligible for a stem cell transplant due to my current health condition or other reasons.
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I have ALCL and have been treated with brentuximab vedotin.
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I am at least 18 years old or the legal adult age in my country.
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My condition worsened after at least one treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to date of first documented objective response of cr, up to approximately 56 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to date of first documented objective response of cr, up to approximately 56 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Secondary outcome measures
Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaExperimental Treatment1 Intervention
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.
Group II: Cohort 1: Relapsed/Refractory Peripheral T-Cell LymphomaExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
388 Previous Clinical Trials
409,363 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,961 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
161 Previous Clinical Trials
78,696 Total Patients Enrolled

Media Library

Valemetostat Tosylate (EZH 1/2 Dual Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04703192 — Phase 2
Peripheral T-Cell Lymphoma Research Study Groups: Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma, Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma Clinical Trial 2023: Valemetostat Tosylate Highlights & Side Effects. Trial Name: NCT04703192 — Phase 2
Valemetostat Tosylate (EZH 1/2 Dual Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04703192 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being sought for this research project at present?

"Although no longer enrolling patients, this clinical trial was posted on June 3rd, 2021 and last edited on October 4th, 2022. According to data from clinicaltrials.gov, there are 1782 other trials that are still recruiting patients."

Answered by AI

How many different facilities are coordinating this experiment?

"This clinical trial is accepting patients at Duke Cancer Center in Durham, New jersey; Ottawa Hospital Research Institute in Ottawa, Pennsylvania; and Hackensack University Medical Center - John Theurer Cancer Center in Hackensack, Missouri. In total, there are 17 other locations where patients can participate."

Answered by AI

What is the risk profile of Valemetostat Tosylate?

"Valemetostat Tosylate has received a score of 2 from our team at Power. This is because while there is data supporting its safety, none of the available information suggests that it is an effective medication."

Answered by AI
~39 spots leftby Mar 2025