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Histone Deacetylase Inhibitor
Tazemetostat + Belinostat for Lymphoma
Phase 1
Recruiting
Led By Jennifer E Amengual
Research Sponsored by National Cancer Institute (NCI)
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 following cycle 2 and 6, and every 3-6 cycles, assessed up to 1 year after completion of study treatment
Awards & highlights
Study Summary
This trial tests a combo of drugs to treat lymphomas that have relapsed or resisted treatment. The drugs may stop tumor growth by blocking enzymes needed for cell growth.
Who is the study for?
Adults with certain types of lymphoma that have come back or haven't responded to treatment can join this trial. They should have tried 1-5 previous treatments, be in fairly good health, and not planning on stem cell or CAR T-cell therapy. People with serious illnesses, pregnant women, and those who've had recent other cancer therapies are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and best dose of tazemetostat combined with belinostat for relapsed/refractory lymphomas. These drugs block enzymes that help cancer cells grow. The study will see if this combo can shrink or stabilize cancer as it has done in animal studies.See study design
What are the potential side effects?
Potential side effects include problems related to liver function, blood counts (like anemia), gastrointestinal issues (nausea, vomiting), fatigue, and possibly increased risk of infection due to immune system effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following cycle 2 and 6, and every 3-6 cycles, assessed up to 1 year after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following cycle 2 and 6, and every 3-6 cycles, assessed up to 1 year after completion of study treatment
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) (Dose escalation)
Secondary outcome measures
Disease response
Duration of response (DOR)
Incidence of adverse events
+7 moreOther outcome measures
Gene signature biomarker for response
Histone acetylation and methylation
Modulation in immune function
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tazemetostat, belinostat)Experimental Treatment7 Interventions
Patients receive tazemetostat PO BID on days 2-21 of cycle 1 and days 1-21 of subsequent cycles, and belinostat IV over 30-180 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo a tumor biopsy during screening and on study (dose-expansion only). Patients undergo blood sample collection while on study and PET/CT scan throughout the study. Patients may also undergo CT scan alone throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography and Computed Tomography Scan
2015
N/A
~20
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Belinostat
2006
Completed Phase 2
~430
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,790 Total Patients Enrolled
Jennifer E AmengualPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
227 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of previous cancer treatments, except for hair loss.My cancer has spread to my brain or spinal cord.I do not have the UGT1A1*28 genetic variation.My heart condition allows me to perform daily activities with slight limitations.My hepatitis B virus load is undetectable with treatment.My steroid medication dose is stable and <= 10 mg/day of prednisone.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I am HIV positive, on treatment, and my viral load is undetectable.I have a history of T-cell lymphoblastic lymphoma or leukemia.I have relapsed or refractory non-Hodgkin lymphoma, including B-cell or T-cell types, or stage 1B or higher CTCL and failed two treatments.I have another cancer type, but it won't affect this trial's treatment.I finished my last cancer treatment at least 2 weeks ago.I am not taking any strong drugs that affect enzyme activity.I can take pills and don't have major stomach or bowel issues affecting drug absorption.My brain scans show no worsening after treatment for brain metastases.I agree to use birth control during and after the study as required.I am allergic to belinostat, tazemetostat, or similar drugs.I have had 1-5 treatments for my condition, even after a transplant.I am not pregnant or breastfeeding and have a negative pregnancy test.My tests show genetic changes linked to MDS and MPN.My kidney function, measured by GFR, is at least 30 mL/min/1.73 m^2.I am not eligible for or have refused stem cell or CAR T-cell therapy.I have severe low blood cell counts or a history of bone marrow diseases.My bilirubin levels are within the normal range, or slightly higher if due to specific conditions.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have a specific type of lymphoma and know if my EZH2 gene is mutated or not.I can understand and am willing to sign the consent form, or I have someone who can do it for me.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tazemetostat, belinostat)
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.
To what extent could taking tazemetostat and belinostat be detrimental to one's health?
"Because of the limited data surrounding its safety and efficacy, Treatment (tazemetostat, belinostat) scored a 1 on our team's risk assessment scale."
Answered by AI
Are applicants being accepted into this trial at the present time?
"According to clinicaltrials.gov, this medical trial is actively enrolling candidates. The initial announcement was made on December 1st 2022 and the latest update was posted on February 3rd 2023."
Answered by AI
What is the highest participant count for this medical experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, posted on December 1st 2022, is presently enrolling patients. 36 subjects are needed from a single medical centre."
Answered by AI
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