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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT02889523
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tazemetostat — DRUG
    Tablets 200 mg, to be administrated per os
  • Rituximab — DRUG
    375 mg/m²/dose, D1
  • Cyclophosphamide — DRUG
    750 mg/m²/dose, D1
  • Vincristine — DRUG
    1.4 mg/m²/dose (max 2 mg), D1
  • Doxorubicin — DRUG
    50 mg/m²/dose, D1
  • Prednisolone — DRUG
    40 mg/m2 in the morning D1 to D5

Study Details

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

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2024
Primary completion
Jan 31, 2023
Completion
Apr 30, 2026

Study Design

Enrollment
214 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DLBCL cohort
    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
  • Experimental: FL cohort
    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)

Primary Outcome Measure

Phase I : Number of Dose Limiting Toxicities [ Time Frame: 1 cycle (1 cycle is 21 days) ]

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