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Valemetostat for T-Cell Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a tumor that can be measured in size using a CT or MRI scan.I have or might have long QT syndrome, or it runs in my family.I have a heart rhythm problem that is not under control, except for stable atrial fibrillation.I have a tumor that can be measured in size using a CT or MRI scan.My condition is ALK-negative anaplastic large cell lymphoma.My heart rate is usually below 50 beats per minute, but I have a pacemaker.I have a history of serious heart rhythm problems.I am at least 18 years old or the legal adult age in my country.I have had at least one treatment for my lymphoma.My leukemia/lymphoma has returned or didn't respond to treatment, and I tested positive for HTLV-1.My cancer did not fully respond to the first or second-line treatments.My T-cell lymphoma diagnosis matches the eligible types listed by WHO.I have a specific type of leukemia/lymphoma that has not responded to treatment.I have ALCL and have been treated with brentuximab vedotin.My lymphoma is ALK positive.I have a specific type of T-cell lymphoma confirmed by a pathologist.My lymphoma is of the T-follicular helper type.I am not eligible for a stem cell transplant due to my health condition or other reasons.I can take care of myself and am up and about more than half of my waking hours.I haven't had major surgery or curative radiation in the last 4 weeks, or palliative radiation in the last 2 weeks.I do not have serious heart problems.I have not had angioplasty or a stent placed in the last 6 months.I have a pacemaker and no recent serious heart rhythm problems.I have not had a heart attack in the last 6 months.I have not had unstable chest pain in the last 6 months.I have severe heart failure.I have not had a heart or leg artery bypass in the last 6 months.I have been treated with EZH inhibitors before.I am not on high-dose steroids, except for short treatments or non-cancer reasons.I am currently taking medication that strongly affects liver enzymes.I can take care of myself and am up and about more than half of my waking hours.My condition is enteropathy-associated T-cell lymphoma.I have been diagnosed with a specific type of intestinal lymphoma.I have been diagnosed with hepatosplenic T-cell lymphoma.I have been diagnosed with a type of skin lymphoma called γδ T-cell.I have been diagnosed with a specific type of skin lymphoma.My condition is PTCL, not otherwise specified.I have been diagnosed with angioimmunoblastic T-cell lymphoma.I have been diagnosed with follicular T-cell lymphoma.My condition worsened or did not improve after at least one treatment.My first cancer treatment did not fully clear the cancer.My cancer did not improve significantly after my second or later treatment.I have had at least one treatment for my T-cell lymphoma.I am not eligible for a stem cell transplant due to my current health condition or other reasons.I have ALCL and have been treated with brentuximab vedotin.I have been diagnosed with a specific type of T-cell leukemia or lymphoma.I have been diagnosed with a specific type of skin lymphoma.I haven't had any cancer except for certain skin, bladder, cervical, or prostate cancers in the last 2 years.My lymphoma has spread to my brain or spinal cord.I had a stem cell transplant using my own cells within the last 60 days.I had a stem cell transplant from a donor within the last 3 months.I have severe GVHD needing strong medication.I haven't had chemotherapy or similar treatments within the last 3 weeks or 5 half-lives of the drug.I am at least 18 years old or the legal adult age in my country.My condition worsened after at least one treatment.
- Group 1: Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
- Group 2: Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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