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Epigenetic Modifier

Tazemetostat for Follicular Lymphoma

Phase 1 & 2
Waitlist Available
Led By Matthew Mei
Research Sponsored by City of Hope Medical Center
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 up to 2 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a combination of drugs to treat follicular lymphoma.

Eligible Conditions
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity
Overall response rate
Secondary outcome measures
Complete response rate
Duration of response
Event-free survival
+2 more

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726
53%
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%
Amylase increased
12%
Herpes simplex
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%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Skin exfoliation
6%
Haematochezia
6%
Pyrexia
6%
Hypogammaglobulinaemia
6%
Electrocardiogram QT prolonged
6%
Hypoalbuminaemia
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Large intestine polyp
6%
Haematuria
6%
Visual field defect
6%
Myalgia
6%
Phlebitis
6%
Tooth disorder
6%
Rash maculo-papular
6%
Gastric cancer
6%
Impetigo
6%
Traumatic fracture
6%
Hypertonic bladder
6%
Upper respiratory tract inflammation
6%
Musculoskeletal chest pain
6%
Traumatic intracranial haemorrhage
6%
Non-small cell lung cancer
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: Treatment (tazemetostat, umbralisib, ublituximab)Experimental Treatment3 Interventions
Patients receive ublituximab IV on days 1, 8, and 15 of cycle 1, day 1 of cycle 2-6, and day 1 of every 3 cycles thereafter. Patients also receive tazemetostat PO BID umbralisib by PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Umbralisib
2015
Completed Phase 2
~60
Ublituximab
2017
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,460 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,881 Total Patients Enrolled
Matthew MeiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

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

Are investigators looking for new participants at this time?

"According to the listing on clinicaltrials.gov, this study is not presently looking for patients as recruitment has closed. The trial was initially posted on December 15th, 2022 and last updated on October 26th, 2022. Even though this particular trial is not ongoing, there are 1796 other trials that are currently recruiting patients."

Answered by AI

What is the total number of patients that will be participating in this experiment?

"Unfortunately, this study is not currently recruiting patients. The listing was first created on December 15th, 2022 and edited most recently on October 26th, 2022. However, there are 35 other trials for Tazemetostat that are looking for participants right now, as well as 1761 studies concerning lymphoma, follicular."

Answered by AI

What are the main purposes for which Tazemetostat is utilized?

"Tazemetostat is a medication used to target b-lymphocytes, but can also be useful in the treatment of other conditions like lymphoma and follicular lymphoma."

Answered by AI

Are there other ongoing experiments that use Tazemetostat?

"Tazemetostat has undergone extensive clinical testing with 35 active studies and 5 trials in Phase 3. The majority of these medical trials are based out of San Antonio, Texas; however, there are 1,627 total locations where Tazemetostat is being studied."

Answered by AI

Does this research have any predecessors?

"Tazemetostat has been researched since 2014 when the first study, sponsored by TG Therapeutics, Inc., was conducted with 45 participants. After Phase 1 approval was received in 2014, there are now 35 active studies involving Tazemetostat being conducted in 581 different cities across 27 countries."

Answered by AI

What is the aim of this clinical trial?

"The aim of this study is to establish the maximum tolerated dose of the medication. To do this, researchers will follow patients for up to 2 years and track any reports of toxicity. Additionally, they will also measure secondary outcomes like complete response rate (defined as the proportion of patients who achieve a complete or partial response), overall survival rate (estimated using the Kaplan-Meier method), and time to response."

Answered by AI
~0 spots leftby Dec 2024