LymphomaPhase 1/2Epi-RCHOPNCT02889523

Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy

A Phase 1/2 study testing Tazemetostat, Rituximab and Cyclophosphamide in people with Lymphoma and DLBCL, run by The Lymphoma Academic Research Organisation at 31 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lymphoma, DLBCL, Follicular Lymphoma
What is being tested?: Tazemetostat, Rituximab and Cyclophosphamide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 31 sitesin 2 countries
Study dates: Oct 2016to Sep 2029
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 28Show fewer

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 defined as:
ANC ≥ 1500/mm3 (≥ 1.5 X 109/L)
Platelets ≥ 75,000/mm3 (≥ 75 X 109/L) without platelet transfusion dependency during the last 7 days
Hemoglobin ≥ 9 g/dL (may receive transfusion)
8. Adequate liver function as defined as:
Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Alkaline phosphatase (in absence of bone disease), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN (or ≤ 5 X ULN if related to lymphoma involvement)
Patients with prior Hepatitis B and C are eligible if, for Hepatitis B detection, surface antigen is negative and/or HBV DNA is undetectable, and for Hepatitis C detection, if HCV RNA is undetectable.
9. Left ventricular ejection fraction (LVEF) ≥ 50% of echocardiography or multiple gated acquisition (MUGA) scan
10. Adequate tissue (surgical excision is recommended) for central pathology review and biological caracterisation (see appendix 11
11. Males with partners of childbearing potential must agree to use reliable forms of contraception during 12 months after last treatment administration
12. Patient covered by any social security system (for France only)
13. Patient who understands and speaks one of the country official languages

Who cannot join

for Cohort DLBCL
15-Previous treatment for B cell lymphoma, except glucocorticoids (no more than 7 days before inclusion, 1 mg/kg/day max)
for Cohort FOLLICULAR ONLY
14bis. Prior therapy for lymphoma including radiotherapy except glucocorticoids (no more than 7 days before inclusion, 1 mg/kg/day max)
17-Pregnant or lactating females
For both Cohorts

Show all 25Show fewer

1-Central nervous system or meningeal involvement
2-Contraindication to any drug contained in the chemotherapy regimen
3-Prior treatment with tazemetostat or other inhibitor of EZH2
4-Patients who are undergoing active treatment for another malignancy, exceptions include: A patient who has been disease free for 2 years, or a patient with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible Patients with prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia(AML) or prior history of T-LBL/T-ALL are excluded whatever receiving treatment or not and whatever date of diagnosis of these pathologies
5-Patients taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John's wort)
6-Patients unwilling to exclude St. John's wort, Seville oranges, grapefruit juice and/or grapefruit from diet
7-Major surgery within 4 weeks before first dose of study drug (minor procedures including transcutaneous biopsy, central line placement are permitted within 2 weeks of enrollment)
8-Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition that would impare ability to take tazemetostat
9-Significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of first dose of tazemetostat or ventricular arrhythmia
10-Not applicable
11-Active uncontrolled infection requiring systemic therapy
12-Congenital immunodeficiency or known HIV (human immunodeficiency virus infection)
13-Any other major illness, that in the investigator's judgement, will substantially increase the risk associated with the patient's participation in the study
14-Patients who have undergone a solid organ transplant
16-Treatment with any investigational drug or device within 30 days before planned first cycle of chemotherapy
18-Person deprived of his/her liberty by a judicial or administrative decision
19-Adult person under legal protection
20-Person hospitalized without consent
21-Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

France28 sites

Centre Hospitalier Victor Dupouy
Argenteuil
CH d'Avignon - Hôpital Henri Dufaut
Avignon
CHU de Besançon - Hôpital Jean Minjoz
Besançon
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
CH de Chambéry
Chambéry
CHU d'Estaing
Clermont-Ferrand, France
APHP - Hopital Henri Mondor
Créteil
CHU de Dijon
Dijon
CHU Grenoble
Grenoble
CH Départemental de Vendée
La Roche-sur-Yon
CHRU Lille - Hôpital Claude Huriez
Lille
Chu de Limoges - Hopital Dupuytren
Limoges
Centre Leon Berard
Lyon
Institut Paoli Calmette
Marseille
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier
CHU de Nantes - Hôtel Dieu
Nantes
APHP - Hôpital de la Pitié Salpetrière
Paris
APHP - Hôpital Saint Louis
Paris
CH de Perpigan
Perpignan
CHU Lyon Sud
Pierre-Bénite
Chu de Poitiers - Hopital de Miletrie
Poitiers
CHU de Rennes - Hôpital Pontchaillou
Rennes
Centre Henri Becquerel
Rouen, 76000
Centre Rene Hugenin
Saint-Cloud
Institut de cancérologie de la Loire
Saint-Priest-en-Jarez
CHRU de Strasbourg
Strasbourg
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse
Institut Gustave Roussy
Villejuif

Other trials in France

Belgium3 sites

Institut Jules Bordet
Brussels
CHU de Liege
Liège
CHRU Mont Godinne
Yvoir

Other trials in Belgium

About this study

Official title: A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP

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

Read the detailed description

Phase I:

Up to 18 patients will be recruited, using a conventional dose-escalation algorithm (3+3 patients per dose level) to identify the maximum tolerated dose (MTD) which will be deemed the RP2D. Patients will receive 8 cycles of RCHOP every 21 days and tazemetostat every day, starting on day 2 of cycle 1.

4 cohorts are defined, according to dose levels of tazemetostat: 400mg Twice a day (BID) (cohort 1, starting level), 600mg BID (cohort 2), 800mg BID (cohort 3), 200mg BID (cohort -1), depending on the observed toxicities.

Phase II:

Up to 184 patients (122 DLBCL and 62 FL) will be recruited and treated with tazemetostat at the MTD and RCHOP.

Patients will receive 6 cycles of RCHOP every 21 days and tazemetostat at the MTD every day, starting on day 2 of cyle 1, + 2 cycles of Rituximab+tazemetostat. For FL, a maintenance of tazemetostat (6 months) + rituximab (24 months) is expected

Conditions: Lymphoma, DLBCL, Follicular Lymphoma
Being tested: Tazemetostat, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin
Keywords: Front line therapy, Age-adjusted International Prognostic Index (aa-IPI) >1, 60 to 80 years
Medical subject headings: Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TazemetostatDrug
Also called EPZ-6438
Tablets 200 mg, to be administrated per os
RituximabDrug
Also called Mabthera
375 mg/m²/dose, D1
CyclophosphamideDrug
750 mg/m²/dose, D1
VincristineDrug
1.4 mg/m²/dose (max 2 mg), D1
DoxorubicinDrug
50 mg/m²/dose, D1
PrednisoloneDrug
40 mg/m2 in the morning D1 to D5

Study groups in NCT02889523
Study group	Role	What they receive
DLBCL cohort	Experimental	RCHOP + tazemetostat: - RCHOP: rituximab (IV, 375 mg/m², day 1), Prednisolone (PO, 40 mg/m² in the morning, day 1 to day 5), doxorubicine (IV, 50 mg/m², day 1), cyclophosphamide (IV, 750 mg/m², day 1), vincristine (IV, 1.4 mg/m², day 1): Phase I : 8 cycles, every 21 days Phase II : 6 cycles, every 21 days * Rituximab (IV, 375 mg/m², day 1) Phase II : 2 cycles, every 21 days * Tazemetostat: PO, doses according to dose cohorts for phase I, and at RP2D for phase II: continuous: Cycle 1: 2 to 21 BID, Cycle 2-8: 1 to 21 BID Receives: Drug: Tazemetostat; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisolone
FL cohort	Experimental	RCHOP + tazemetostat: Induction * RCHOP: rituximab (IV, 375 mg/m², day 1), Prednisolone (PO, 40 mg/m² in the morning, day 1 to day 5), doxorubicine (IV, 50 mg/m², day 1), cyclophosphamide (IV, 750 mg/m², day 1), vincristine (IV, 1.4 mg/m², day 1): 6 cycles, every 21 days * Rituximab (IV, 375 mg/m², day 1) Phase II : 2 cycles, every 21 days * Tazemetostat: PO, RP2D, continuous: Cycle 1: 2 to 21 BID, Cycle 2-8: 1 to 21 BID Maintenance * Tazemetostat : 6 months (every 8 weeks) * Rituximab : 24 months (every 8 weeks) Receives: Drug: Tazemetostat; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase I : Number of Dose Limiting Toxicities
Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT's in cycle 1 and 2 in order to establish the MTD/RP2D
Measured: 1 cycle (1 cycle is 21 days)
Phase I : Number of Dose Limiting Toxicities
Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT's in cycle 1 and 2 in order to establish the MTD/RP2D
Measured: 2 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Complete Response Rate based on local assessment
Complete response rate as determined by Cheson International Work Group (IWG) 2014: Lugano Classification (Deauville scale 1-3)
Measured: 8 cycles (1 cycle is 21 days)
Phase II - FL Cohort : Complete Response Rate based on local assessment
Complete response rate as determined by Cheson IWG 2014: Lugano Classification (Deauville scale 1-3)
Measured: 8 cycles (1 cycle is 21 days)

Secondary outcomes (25)

Phase I : Serum concentration of CHOP components in presence/absence of Tazemetostat
Measured: Change between baseline - 1 month
Phase I : Serum concentration of Tazemetostat and its metabolite (EZH 6930) in presence of CHOP
Measured: Change between baseline - 1 month
Phase I : Complete response rate (CRR) by central review using Cheson IWG criteria
Measured: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Number of Adverse Events (AE)/Serious Adverse Events (SAE)
Measured: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Complete response rate (CRR) by central review using Cheson IWG criteria
Measured: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Measured: 52 weeks
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Measured: 104 weeks
Phase II - DLBCL Cohort : progression free survival (PFS)
Measured: 52 weeks
Phase II - DLBCL Cohort : progression free survival (PFS)
Measured: 104 weeks
Phase II - DLBCL Cohort : duration of response (DR)
Measured: 52 weeks
Phase II - DLBCL Cohort : duration of response (DR)
Measured: 104 weeks
Phase II - DLBCL Cohort : overall survival (OS)
Measured: 52 weeks
Phase II - DLBCL Cohort : overall survival (OS)
Measured: 104 weeks
Phase II - DLBCL Cohort : best overall response (BOR)
Measured: 104 weeks
Phase II - FL cohort : Number of AE/SAE
Measured: 8 cycles (1 cycle is 21 days)
Phase II - FL cohort : Number of AE/SAE
Measured: 13 months
Phase II - FL cohort : PET Complete Response Rate (PET-CRR) by central review according to Lugano 2014 criteria
Measured: 8 cycles (1 cycle is 21 days)
Phase II - FL cohort : Complete Response Rate (CRR)
Measured: 31 months
Phase II - FL cohort : Overall Response Rate (CRR)
Measured: 31 months
Phase II - FL cohort : Progression Free Survival (PFS)
Measured: 24 months
Phase II - FL cohort : Progression Free Survival (PFS)
Measured: 31 months
Phase II - FL cohort : Event Free Survival (EFS)
Measured: 24 months
Phase II - FL cohort : Overall Survival (OS)
Measured: 24 months
Phase II - FL cohort : Duration of Response (DR)
Measured: 31 months
Phase II - FL cohort : Best Overall Response
Measured: 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Sep 2029

First posted5 Sep 2016 (estimated)
Study startOct 2016
Primary completion31 Jan 2023
Study completionSep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02889523
Sponsor's protocol ID: Epi-RCHOP
Acronym: Epi-RCHOP
Status last verified: Jul 2026
First submitted: 11 Jul 2016
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Sarkozy C, Morschhauser F, Dubois S, Molina T, Michot JM, Cullieres-Dartigues P, Suttle B, Karlin L, Le Gouill S, Picquenot JM, Dubois R, Tilly H, Herbaux C, Jardin F, Salles G, Ribrag V. A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features. Clin Cancer Res. 2020 Jul 1;26(13):3145-3153. doi: 10.1158/1078-0432.CCR-19-3741. Epub 2020 Mar 2.
PubMed 32122924

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP
ClinicalTrials.gov ID: NCT02889523
Acronym / sponsor ID: Epi-RCHOP / Epi-RCHOP
Conditions: Lymphoma, DLBCL, Follicular Lymphoma
Keywords: Front line therapy, Age-adjusted International Prognostic Index (aa-IPI) >1, 60 to 80 years
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 214 participants (actual)
Lead sponsor: The Lymphoma Academic Research OrganisationUniversity, hospital or other
Collaborators: Epizyme, Inc.
Study start: Oct 2016 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: Sep 2029 (estimated)
First posted: 5 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 :

Detailed description

Phase I:

Phase II:

Up to 184 patients (122 DLBCL and 62 FL) will be recruited and treated with tazemetostat at the MTD and RCHOP.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DLBCL cohort	Experimental	Drug: Tazemetostat, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Doxorubicin, Drug: PrednisoloneRCHOP + tazemetostat: - RCHOP: rituximab (IV, 375 mg/m², day 1), Prednisolone (PO, 40 mg/m² in the morning, day 1 to day 5), doxorubicine (IV, 50 mg/m², day 1), cyclophosphamide (IV, 750 mg/m², day 1), vincristine (IV, 1.4 mg/m², day 1): Phase I : 8 cycles, every 21 days Phase II : 6 cycles, every 21 days * Rituximab (IV, 375 mg/m², day 1) Phase II : 2 cycles, every 21 days * Tazemetostat: PO, doses according to dose cohorts for phase I, and at RP2D for phase II: continuous: Cycle 1: 2 to 21 BID, Cycle 2-8: 1 to 21 BID
FL cohort	Experimental	Drug: Tazemetostat, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Doxorubicin, Drug: PrednisoloneRCHOP + tazemetostat: Induction * RCHOP: rituximab (IV, 375 mg/m², day 1), Prednisolone (PO, 40 mg/m² in the morning, day 1 to day 5), doxorubicine (IV, 50 mg/m², day 1), cyclophosphamide (IV, 750 mg/m², day 1), vincristine (IV, 1.4 mg/m², day 1): 6 cycles, every 21 days * Rituximab (IV, 375 mg/m², day 1) Phase II : 2 cycles, every 21 days * Tazemetostat: PO, RP2D, continuous: Cycle 1: 2 to 21 BID, Cycle 2-8: 1 to 21 BID Maintenance * Tazemetostat : 6 months (every 8 weeks) * Rituximab : 24 months (every 8 weeks)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Key exclusion criteria (25 listed)

15-Previous treatment for B cell lymphoma, except glucocorticoids (no more than 7 days before inclusion, 1 mg/kg/day max)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TazemetostatAlso: EPZ-6438Tablets 200 mg, to be administrated per os	Drug	DLBCL cohort, FL cohort
RituximabAlso: Mabthera375 mg/m²/dose, D1	Drug	DLBCL cohort, FL cohort
Cyclophosphamide750 mg/m²/dose, D1	Drug	DLBCL cohort, FL cohort
Vincristine1.4 mg/m²/dose (max 2 mg), D1	Drug	DLBCL cohort, FL cohort
Doxorubicin50 mg/m²/dose, D1	Drug	DLBCL cohort, FL cohort
Prednisolone40 mg/m2 in the morning D1 to D5	Drug	DLBCL cohort, FL cohort

Primary outcome

Phase I : Number of Dose Limiting Toxicities
Time frame: 1 cycle (1 cycle is 21 days)
Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT's in cycle 1 and 2 in order to establish the MTD/RP2D
Phase I : Number of Dose Limiting Toxicities
Time frame: 2 cycles (1 cycle is 21 days)
Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT's in cycle 1 and 2 in order to establish the MTD/RP2D
Phase II - DLBCL Cohort : Complete Response Rate based on local assessment
Time frame: 8 cycles (1 cycle is 21 days)
Complete response rate as determined by Cheson International Work Group (IWG) 2014: Lugano Classification (Deauville scale 1-3)
Phase II - FL Cohort : Complete Response Rate based on local assessment
Time frame: 8 cycles (1 cycle is 21 days)
Complete response rate as determined by Cheson IWG 2014: Lugano Classification (Deauville scale 1-3)

25 secondary outcomes

Phase I : Serum concentration of CHOP components in presence/absence of Tazemetostat
Time frame: Change between baseline - 1 month
Phase I : Serum concentration of Tazemetostat and its metabolite (EZH 6930) in presence of CHOP
Time frame: Change between baseline - 1 month
Phase I : Complete response rate (CRR) by central review using Cheson IWG criteria
Time frame: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Number of Adverse Events (AE)/Serious Adverse Events (SAE)
Time frame: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Complete response rate (CRR) by central review using Cheson IWG criteria
Time frame: 8 cycles (1 cycle is 21 days)
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Time frame: 52 weeks
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Time frame: 104 weeks
Phase II - DLBCL Cohort : progression free survival (PFS)
Time frame: 52 weeks
Phase II - DLBCL Cohort : progression free survival (PFS)
Time frame: 104 weeks
Phase II - DLBCL Cohort : duration of response (DR)
Time frame: 52 weeks
Phase II - DLBCL Cohort : duration of response (DR)
Time frame: 104 weeks
Phase II - DLBCL Cohort : overall survival (OS)
Time frame: 52 weeks
Phase II - DLBCL Cohort : overall survival (OS)
Time frame: 104 weeks
Phase II - DLBCL Cohort : best overall response (BOR)
Time frame: 104 weeks
Phase II - FL cohort : Number of AE/SAE
Time frame: 8 cycles (1 cycle is 21 days)
Phase II - FL cohort : Number of AE/SAE
Time frame: 13 months
Phase II - FL cohort : PET Complete Response Rate (PET-CRR) by central review according to Lugano 2014 criteria
Time frame: 8 cycles (1 cycle is 21 days)
Phase II - FL cohort : Complete Response Rate (CRR)
Time frame: 31 months
Phase II - FL cohort : Overall Response Rate (CRR)
Time frame: 31 months
Phase II - FL cohort : Progression Free Survival (PFS)
Time frame: 24 months
Phase II - FL cohort : Progression Free Survival (PFS)
Time frame: 31 months
Phase II - FL cohort : Event Free Survival (EFS)
Time frame: 24 months
Phase II - FL cohort : Overall Survival (OS)
Time frame: 24 months
Phase II - FL cohort : Duration of Response (DR)
Time frame: 31 months
Phase II - FL cohort : Best Overall Response
Time frame: 31 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Derived from this study: PubMed 32122924Sarkozy C, Morschhauser F, Dubois S, Molina T, Michot JM, Cullieres-Dartigues P, Suttle B, Karlin L, Le Gouill S, Picquenot JM, Dubois R, Tilly H, Herbaux C, Jardin F, Salles G, Ribrag V. A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features. Clin Cancer Res. 2020 Jul 1;26(13):3145-3153. doi: 10.1158/1078-0432.CCR-19-3741. Epub 2020 Mar 2.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vincent Ribrag, MD study chair

Institut Gustave Roussy Cancer Campus Grand Paris

Clémentine Sarkozy, MD study chair

Institut Gustave Roussy Cancer Campus Grand Paris

Franck Morshhauser, Pr study chair

Centre Régional Hospitalier de Lille

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tazemetostat, Rituximab and Cyclophosphamide in people with Lymphoma and DLBCL, run by The Lymphoma Academic Research Organisation at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I : Number of Dose Limiting Toxicities (time frame: 1 cycle (1 cycle is 21 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02889523, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.