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

NCT02889523 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-10-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tazemetostat

Tablets 200 mg, to be administrated per os

DRUG

Rituximab

375 mg/m²/dose, D1

DRUG

Cyclophosphamide

750 mg/m²/dose, D1

DRUG

Vincristine

1.4 mg/m²/dose (max 2 mg), D1

DRUG

Doxorubicin

50 mg/m²/dose, D1

DRUG

Prednisolone

40 mg/m2 in the morning D1 to D5

Sponsors & Collaborators

  • Epizyme, Inc.

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Vincent Ribrag, MD · Institut Gustave Roussy Cancer Campus Grand Paris

  • Clémentine Sarkozy, MD · Institut Gustave Roussy Cancer Campus Grand Paris

  • Franck Morshhauser, Pr · Centre Régional Hospitalier de Lille

  • Loic Ysebaert, MD · IUCT Oncopole de Toulouse

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2023-01-31
Completion
2026-04-30

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889523 on ClinicalTrials.gov