Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Tr… (NCT02889523) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy
Belgium, France214 participantsStarted 2016-10
Plain-language summary
Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21.
Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients :
DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA
* for Cohort DLBCL ONLY
* 1-Patients with an untreated DLBCL de novo or transformed from indolent lymphoma (CD 20 positive) with
* Phase Ib aaIPI ≥ 2
* Phase II: aaIPI ≥ 1ONLY
* 2\. Age between 60 and 80 years included
* for Cohort FOLLICULAR ONLY
* 1-High Tumor Burden (as defined by GELF criteria \> 0) frontline follicular lymphoma (FL) with high risk FLIPI 3-5
* 2\. Aged between 18 years and 80 years included
* 11bis. Females of childbearing potential (FCBP) must agree to use one reliable form of contraception or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 12 months after discontinuation of any study treatments (R-CHOP, tazemetostat, Rituximab)
* For both Cohorts
* 1bis- For phase II patients: Bi-dimensionally measurable disease defined by at least one single node or tumor lesion \> 1.5 cm assessed by CT scan and/or clinical examination AND a FDG avid disease by PETscan
* 3.ECOG performance status of 0, 1 or 2 (0 or 1 only for phase Ib)
* 4.Signed informed consent
* 5.Life expectancy of ≥ 90 days (3 months) before starting tazemetostat
* 6.Adequate renal function as calculated by a creatinine clearance \> 40 mL/min by local institutional formula
* 7\. Adequate bone marrow function as defi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I : Number of Dose Limiting Toxicities
Timeframe: 1 cycle (1 cycle is 21 days)
2
Phase I : Number of Dose Limiting Toxicities
Timeframe: 2 cycles (1 cycle is 21 days)
3
Phase II - DLBCL Cohort : Complete Response Rate based on local assessment
Timeframe: 8 cycles (1 cycle is 21 days)
4
Phase II - FL Cohort : Complete Response Rate based on local assessment
Timeframe: 8 cycles (1 cycle is 21 days)
Trial details
NCT IDNCT02889523
SponsorThe Lymphoma Academic Research Organisation