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EZH2 Inhibitor
Tazemetostat for Lymphoma
Phase 1
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial will assess an oral drug (Tazemetostat) for people with relapsed/refractory follicular lymphoma, T-cell lymphoma, or Chronic Lymphocytic Leukemia.
Who is the study for?
Adults with certain types of peripheral T-cell lymphoma (PTCL) that have come back or haven't responded to treatment can join. They need good liver and kidney function, stable heart performance, and no dependence on blood transfusions. People with HIV, Hepatitis B or C are eligible if their conditions are well-managed. Women who can have children must not be pregnant, agree to pregnancy tests, and use effective birth control.Check my eligibility
What is being tested?
The trial is testing Tazemetostat, an oral medication designed to inhibit a protein called EZH2 in patients with specific lymphoid malignancies. It's for those whose disease has returned after treatment or hasn't improved at all despite previous therapies.See study design
What are the potential side effects?
Tazemetostat may cause fatigue, nausea, loss of appetite, changes in taste perception or hair thinning. More serious side effects could include low blood cell counts leading to increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify the recommended phase II dose of Tazemetostat
Side effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Weight decreased
18%
Blood creatinine increased
18%
Neutropenia
18%
Nausea
12%
Urinary tract infection
12%
Influenza
12%
Pneumonia
12%
Herpes simplex
12%
Amylase increased
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Bronchitis
6%
Aspartate aminotransferase increased
6%
Osteonecrosis of jaw
6%
Insomnia
6%
Abdominal pain
6%
Fatigue
6%
Oedema peripheral
6%
Blood pressure decreased
6%
Gastroenteritis
6%
Immature granulocyte count increased
6%
Traumatic fracture
6%
Hypertonic bladder
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Skin exfoliation
6%
Non-small cell lung cancer
6%
Haematochezia
6%
Pyrexia
6%
Hypogammaglobulinaemia
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Musculoskeletal chest pain
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Large intestine polyp
6%
Haematuria
6%
Traumatic intracranial haemorrhage
6%
Gastric cancer
6%
Visual field defect
6%
Upper respiratory tract inflammation
6%
Myalgia
6%
Phlebitis
6%
Impetigo
6%
Tooth disorder
6%
Rash maculo-papular
6%
Alanine aminotransferase increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cohort AExperimental Treatment1 Intervention
T-cell Lymphomas
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,280,043 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Hepatitis B but am on treatment and my viral load is undetectable.I had a stem cell transplant using my own cells within the last 3 months.My cancer has spread to my brain or spinal cord.I am taking medication that weakens my immune system.I had a stem cell transplant from a donor within the last 6 months.I cannot swallow or keep down oral medications.I do not have issues absorbing nutrients or uncontrolled GI problems.I had an organ transplant less than 3 years ago.I am 18 years old or older.I have not had major surgery in the last 4 weeks.My disease has returned or is not responding to treatment.I have had at least one treatment for peripheral T-cell lymphoma.My liver, kidneys, blood counts, and heart function are all within normal ranges.I have at least one tumor that can be measured on a PET/CT scan.I have not received any live vaccines in the last 28 days.I can take care of myself and am up and about more than half of my waking hours.I have had myeloid cancer or T-cell lymphoblastic cancer before.I am not pregnant.I finished my last cancer treatment less than 4 weeks ago.My lymphoma is a type of PTCL as classified by WHO in 2022.I have been treated with an EZH2 inhibitor before.I have taken 10 mg or more of prednisone in the last week.I do not have any active cancer except for certain allowed types.I had Hepatitis C but have completed treatment and now have no detectable virus.I have HIV, am on treatment, my CD4+ count is above 350, and I have no detectable viral load.I do not have any serious illnesses that would stop me from joining.My lymphoma is of a specific subtype.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Cohort A a secure environment for human participants?
"Owing to the limited clinical data related to Cohort A's efficacy and safety, our team assigned it a score of 1 on the scale from 1-3."
Answered by AI
Are there any open slots for new participants in this experiment?
"From what is posted on clinicaltrials.gov, this trial has ceased its recruitment efforts at the moment as it was last edited on August 1st 2023 and initially posted 9/1/2023. Although inactive currently, there are a plethora of alternative studies looking for participants right now with 1730 other trials actively searching."
Answered by AI
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