search
Back to results

Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy (Epi-RCHOP)

Primary Purpose

Lymphoma, DLBCL, Follicular Lymphoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tazemetostat
Rituximab
Cyclophosphamide
Vincristine
Doxorubicin
Prednisolone
Sponsored by
The Lymphoma Academic Research Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Front line therapy, Age-adjusted International Prognostic Index (aa-IPI) >1, 60 to 80 years

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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 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
  • EXCLUSION CRITERIA

    • 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

      • 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

Sites / Locations

  • Institut Jules Bordet
  • CHU de Liege
  • CHRU Mont Godinne
  • Centre Hospitalier Victor Dupouy
  • CH d'Avignon - Hôpital Henri Dufaut
  • CHU de Besançon - Hôpital Jean Minjoz
  • Polyclinique Bordeaux Nord Aquitaine
  • CH de Chambéry
  • CHU d'Estaing
  • APHP - Hopital Henri Mondor
  • CHU de Dijon
  • CHU Grenoble
  • CH Départemental de Vendée
  • CHRU Lille - Hôpital Claude Huriez
  • Chu de Limoges - Hopital Dupuytren
  • Centre Leon Berard
  • Institut Paoli Calmette
  • CHU de Montpellier - Hôpital Saint-Eloi
  • CHU de Nantes - Hôtel Dieu
  • APHP - Hôpital Saint Louis
  • APHP - Hôpital de la Pitié Salpetrière
  • CH de Perpigan
  • CHU Lyon Sud
  • Chu de Poitiers - Hopital de Miletrie
  • CHU de Rennes - Hôpital Pontchaillou
  • Centre Henri Becquerel
  • Centre Rene Hugenin
  • Institut de cancérologie de la Loire
  • CHRU de Strasbourg
  • Institut Universitaire du Cancer de Toulouse - Oncopole
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DLBCL cohort

FL cohort

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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
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
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)
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)

Secondary Outcome Measures

Phase I : Serum concentration of CHOP components in presence/absence of Tazemetostat
Phase I : Serum concentration of Tazemetostat and its metabolite (EZH 6930) in presence of CHOP
Phase I : Complete response rate (CRR) by central review using Cheson IWG criteria
Phase II - DLBCL Cohort : Number of Adverse Events (AE)/Serious Adverse Events (SAE)
Phase II - DLBCL Cohort : Complete response rate (CRR) by central review using Cheson IWG criteria
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Phase II - DLBCL Cohort : progression free survival (PFS)
Phase II - DLBCL Cohort : progression free survival (PFS)
Phase II - DLBCL Cohort : duration of response (DR)
Phase II - DLBCL Cohort : duration of response (DR)
Phase II - DLBCL Cohort : overall survival (OS)
Phase II - DLBCL Cohort : overall survival (OS)
Phase II - DLBCL Cohort : best overall response (BOR)
Phase II - FL cohort : Number of AE/SAE
Phase II - FL cohort : Number of AE/SAE
Phase II - FL cohort : PET Complete Response Rate (PET-CRR) by central review according to Lugano 2014 criteria
Phase II - FL cohort : Complete Response Rate (CRR)
Phase II - FL cohort : Overall Response Rate (CRR)
Phase II - FL cohort : Progression Free Survival (PFS)
Phase II - FL cohort : Progression Free Survival (PFS)
Phase II - FL cohort : Event Free Survival (EFS)
Phase II - FL cohort : Overall Survival (OS)
Phase II - FL cohort : Duration of Response (DR)
Phase II - FL cohort : Best Overall Response

Full Information

First Posted
July 11, 2016
Last Updated
March 16, 2023
Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Epizyme, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02889523
Brief Title
Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy
Acronym
Epi-RCHOP
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Epizyme, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, DLBCL, Follicular Lymphoma
Keywords
Front line therapy, Age-adjusted International Prognostic Index (aa-IPI) >1, 60 to 80 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLBCL cohort
Arm Type
Experimental
Arm Description
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
Arm Title
FL cohort
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Tazemetostat
Other Intervention Name(s)
EPZ-6438
Intervention Description
Tablets 200 mg, to be administrated per os
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
375 mg/m²/dose, D1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/m²/dose, D1
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m²/dose (max 2 mg), D1
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/m²/dose, D1
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
40 mg/m2 in the morning D1 to D5
Primary Outcome Measure Information:
Title
Phase I : Number of Dose Limiting Toxicities
Description
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
Time Frame
1 cycle (1 cycle is 21 days)
Title
Phase I : Number of Dose Limiting Toxicities
Description
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
Time Frame
2 cycles (1 cycle is 21 days)
Title
Phase II - DLBCL Cohort : Complete Response Rate based on local assessment
Description
Complete response rate as determined by Cheson International Work Group (IWG) 2014: Lugano Classification (Deauville scale 1-3)
Time Frame
8 cycles (1 cycle is 21 days)
Title
Phase II - FL Cohort : Complete Response Rate based on local assessment
Description
Complete response rate as determined by Cheson IWG 2014: Lugano Classification (Deauville scale 1-3)
Time Frame
8 cycles (1 cycle is 21 days)
Secondary Outcome Measure Information:
Title
Phase I : Serum concentration of CHOP components in presence/absence of Tazemetostat
Time Frame
Change between baseline - 1 month
Title
Phase I : Serum concentration of Tazemetostat and its metabolite (EZH 6930) in presence of CHOP
Time Frame
Change between baseline - 1 month
Title
Phase I : Complete response rate (CRR) by central review using Cheson IWG criteria
Time Frame
8 cycles (1 cycle is 21 days)
Title
Phase II - DLBCL Cohort : Number of Adverse Events (AE)/Serious Adverse Events (SAE)
Time Frame
8 cycles (1 cycle is 21 days)
Title
Phase II - DLBCL Cohort : Complete response rate (CRR) by central review using Cheson IWG criteria
Time Frame
8 cycles (1 cycle is 21 days)
Title
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Time Frame
52 weeks
Title
Phase II - DLBCL Cohort : Overall response rate (ORR) by central review
Time Frame
104 weeks
Title
Phase II - DLBCL Cohort : progression free survival (PFS)
Time Frame
52 weeks
Title
Phase II - DLBCL Cohort : progression free survival (PFS)
Time Frame
104 weeks
Title
Phase II - DLBCL Cohort : duration of response (DR)
Time Frame
52 weeks
Title
Phase II - DLBCL Cohort : duration of response (DR)
Time Frame
104 weeks
Title
Phase II - DLBCL Cohort : overall survival (OS)
Time Frame
52 weeks
Title
Phase II - DLBCL Cohort : overall survival (OS)
Time Frame
104 weeks
Title
Phase II - DLBCL Cohort : best overall response (BOR)
Time Frame
104 weeks
Title
Phase II - FL cohort : Number of AE/SAE
Time Frame
8 cycles (1 cycle is 21 days)
Title
Phase II - FL cohort : Number of AE/SAE
Time Frame
13 months
Title
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)
Title
Phase II - FL cohort : Complete Response Rate (CRR)
Time Frame
31 months
Title
Phase II - FL cohort : Overall Response Rate (CRR)
Time Frame
31 months
Title
Phase II - FL cohort : Progression Free Survival (PFS)
Time Frame
24 months
Title
Phase II - FL cohort : Progression Free Survival (PFS)
Time Frame
31 months
Title
Phase II - FL cohort : Event Free Survival (EFS)
Time Frame
24 months
Title
Phase II - FL cohort : Overall Survival (OS)
Time Frame
24 months
Title
Phase II - FL cohort : Duration of Response (DR)
Time Frame
31 months
Title
Phase II - FL cohort : Best Overall Response
Time Frame
31 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 EXCLUSION CRITERIA 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Ribrag, MD
Organizational Affiliation
Institut Gustave Roussy Cancer Campus Grand Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clémentine Sarkozy, MD
Organizational Affiliation
Institut Gustave Roussy Cancer Campus Grand Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Franck Morshhauser, Pr
Organizational Affiliation
Centre Régional Hospitalier de Lille
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Loic Ysebaert, MD
Organizational Affiliation
IUCT Oncopole de Toulouse
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
CHU de Liege
City
Liege
Country
Belgium
Facility Name
CHRU Mont Godinne
City
Yvoir
Country
Belgium
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
Country
France
Facility Name
CH d'Avignon - Hôpital Henri Dufaut
City
Avignon
Country
France
Facility Name
CHU de Besançon - Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Facility Name
CH de Chambéry
City
Chambéry
Country
France
Facility Name
CHU d'Estaing
City
Clermont-Ferrand
Country
France
Facility Name
APHP - Hopital Henri Mondor
City
Creteil
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
CH Départemental de Vendée
City
La Roche sur Yon
Country
France
Facility Name
CHRU Lille - Hôpital Claude Huriez
City
Lille Cedex
Country
France
Facility Name
Chu de Limoges - Hopital Dupuytren
City
Limoges
Country
France
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
Country
France
Facility Name
CHU de Montpellier - Hôpital Saint-Eloi
City
Montpellier
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
Country
France
Facility Name
APHP - Hôpital Saint Louis
City
Paris Cedex 10
Country
France
Facility Name
APHP - Hôpital de la Pitié Salpetrière
City
Paris
Country
France
Facility Name
CH de Perpigan
City
Perpignan
Country
France
Facility Name
CHU Lyon Sud
City
Pierre-Bénite Cedex
Country
France
Facility Name
Chu de Poitiers - Hopital de Miletrie
City
Poitiers
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Centre Rene Hugenin
City
Saint Cloud
Country
France
Facility Name
Institut de cancérologie de la Loire
City
Saint Priest en Jarez
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32122924
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs