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Epigenetic Modulator
Tazemetostat + Venetoclax for Lymphoma
Phase 1
Recruiting
Led By Lisa Roth, M.D.
Research Sponsored by Weill Medical College of Cornell University
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 from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, as assessed at 5 years
Awards & highlights
Study Summary
This trial is testing tazemetostat & venetoclax combo to treat R/R NHL. Participants take pills daily & come to clinic for tests/imaging to monitor side effects & cancer progression.
Who is the study for?
This trial is for individuals with relapsed/refractory Non-Hodgkin Lymphoma who have had at least one prior treatment and are either post-autologous stem cell transplant or ineligible for it. They must be able to take pills orally, not have a history of certain conditions like major surgery recently, uncontrolled infections, or known allergies to the study drugs.Check my eligibility
What is being tested?
The trial studies how well tazemetostat and venetoclax work together in treating Non-Hodgkin Lymphoma that has come back or didn't respond to previous treatments. It aims to find the best dose, understand side effects, and see the effect on cancer over up to 24 months with regular clinic visits.See study design
What are the potential side effects?
Potential side effects from tazemetostat and venetoclax may include digestive issues, risk of infection due to low blood counts, fatigue, liver problems, bleeding complications. Specific reactions will vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of treatment initiation until the date of death from any cause, as assessed at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of treatment initiation until the date of death from any cause, as assessed at 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum-tolerated dose (MTD) determination (Part 1)
Number of adverse events (AEs) by severity from baseline to 30 days, after the last dose of study drug as assessed, by CTCAE v5.0
Number of participants who experience adverse events (AEs), from baseline to 30 days after the last dose of study drug, as assessed by CTCAE v5.0
+1 moreSecondary outcome measures
Duration of Response (DoR)
Number of Participants who Achieve Complete Response (CR)
Number of Participants who Achieve Partial Response (PR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tazemetostat and VenetoclaxExperimental Treatment2 Interventions
All participants will receive a combination of oral 800 mg tazemetostat BID and oral venetoclax. Since this is a phase 1 trial, the dose of venetoclax will be determined by the investigators per a sequential dose escalation (3+3). Participants will be provided study drug in the form of pills to take at home. Study participants will need to regularly come to the clinic for blood work, imaging, and to monitor and side effects. Participants may receive study drug until their cancer progresses or for up to 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Tazemetostat
2016
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,257 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,105 Total Patients Enrolled
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,888 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an uncontrolled HIV or HTLV-1 infection.My CLL has transformed into a more aggressive form.I cannot swallow pills.I have previously been treated with tazemetostat or venetoclax.I do not have an untreated infection.I have had cancer before, but it might still be okay.I cannot take medicine by mouth due to a digestive condition.I do not have a significant history of liver disease.I have not had a blood clot or lung clot in the past 3 months.I have had a solid organ transplant.I have not had major surgery in the last 3 weeks.I have a history of T-cell lymphoblastic lymphoma/leukemia.I need to take warfarin.My lymphoma has worsened after at least one treatment.My cancer has spread to my brain or spinal cord.My diagnosis of follicular lymphoma or diffuse large B-cell lymphoma is confirmed by a biopsy.I have not had serious heart problems or a stroke in the last 6 months.I have not received any live vaccines in the last 28 days.My condition worsened after a stem cell transplant, or I am not eligible for one.I am not on any strong medications that affect liver enzymes or certain heart medications.
Research Study Groups:
This trial has the following groups:- Group 1: Tazemetostat and Venetoclax
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.
What is the intended outcome of this exploration?
"According to the trial sponsor, Epizyme Inc., this medical study will span 25 months and measure Maximum-Tolerated Dose (MTD) as its primary outcome. Secondary outcomes include Progression-Free Survival (PFS), Overall Response Rate (ORR), and Duration of Response (DoR). ORR is defined by Lugano response criteria, CR & PR are measured from start of treatment until progression or death from any cause, while DoR is calculated from first recorded objective documentation until recurrent disease appears."
Answered by AI
What potential health hazards can be associated with Tazemetostat and Venetoclax use?
"Our assessment of the safety profiles of Tazemetostat and Venetoclax is a 1 due to their Phase 1 status, which implies that there are limited data regarding efficacy or any potential risks."
Answered by AI
Are there unfilled vacancies for participants in this clinical trial?
"According to the data posted on clinicaltrials.gov, this trial has concluded its recruitment phase and is no longer accepting participants. Initially published in December 2022 and last updated November 15th of that year, it does not seem likely for additional enrollees to be accepted at this time; however, there are 1791 other trials currently recruiting patients."
Answered by AI
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