BTCRC-LYM20-463: A basic final study report

A Single Arm Phase I/II Study of Tazemetostat with Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma

Author

Lu Mao

Published

July 2, 2026

Analysis population

For this draft table, We summarize all registered subjects with available demographic data. The table is stratified by a working analysis cohort:

  • Phase I non-RP2D: Phase I subjects treated below the RP2D dose level
  • RP2D / Phase II efficacy population: Phase II subjects plus Phase I subjects treated at the RP2D dose level
Basic checks for demographic analysis dataset
analysis_cohort phase dose_level n
Phase I non-RP2D Phase I Phase I dose level 1: 400 mg BID 3
Phase I non-RP2D Phase I Phase I dose level 2: 600 mg BID 3
RP2D / Phase II efficacy population Phase I Phase I dose level 3/RP2D: 800 mg BID 6
RP2D / Phase II efficacy population Phase II Phase II/RP2D: 800 mg BID 24

Demographics and baseline characteristics

Characteristic
Analysis cohort
Phase I non-RP2D
N = 61		 RP2D / Phase II efficacy population
N = 301		 Overall
N = 361
Age at registration, years


    Median (Q1, Q3) 66.5 (64.0, 70.0) 57.5 (50.0, 67.0) 58.5 (50.5, 68.0)
    Min, Max 44.0, 70.0 35.0, 76.0 35.0, 76.0
Sex


    Female 1 (16.7%) 17 (56.7%) 18 (50.0%)
    Male 5 (83.3%) 13 (43.3%) 18 (50.0%)
Race


    Asian 0 (0.0%) 2 (6.7%) 2 (5.6%)
    Unknown 0 (0.0%) 2 (6.7%) 2 (5.6%)
    White 6 (100.0%) 26 (86.7%) 32 (88.9%)
Ethnicity


    Hispanic or Latino 0 (0.0%) 3 (10.0%) 3 (8.3%)
    Non-Hispanic 6 (100.0%) 26 (86.7%) 32 (88.9%)
    Unknown 0 (0.0%) 1 (3.3%) 1 (2.8%)
Study site


    1 S Park St Medical Center 1 (16.7%) 2 (6.7%) 3 (8.3%)
    Northwestern Memorial Hospital 0 (0.0%) 5 (16.7%) 5 (13.9%)
    OSU James Outpatient Care - West Campus 1 (16.7%) 9 (30.0%) 10 (27.8%)
    Rutgers Cancer Institute of New Jersey 4 (66.7%) 4 (13.3%) 8 (22.2%)
    RWJ Barnabas Health Cooperman Barnabas Medical Center 0 (0.0%) 1 (3.3%) 1 (2.8%)
    University of Illinois Hospital and Health Systems (Outpatient Cancer Center) 0 (0.0%) 1 (3.3%) 1 (2.8%)
    University of Wisconsin Carbone Cancer Center - University Hospital 0 (0.0%) 5 (16.7%) 5 (13.9%)
    UW Health Eastpark Medical Center 0 (0.0%) 3 (10.0%) 3 (8.3%)
Study phase


    Phase I 6 (100.0%) 6 (20.0%) 12 (33.3%)
    Phase II 0 (0.0%) 24 (80.0%) 24 (66.7%)
Tazemetostat dose cohort


    Phase I dose level 1: 400 mg BID 3 (50.0%) 0 (0.0%) 3 (8.3%)
    Phase I dose level 2: 600 mg BID 3 (50.0%) 0 (0.0%) 3 (8.3%)
    Phase I dose level 3/RP2D: 800 mg BID 0 (0.0%) 6 (20.0%) 6 (16.7%)
    Phase II/RP2D: 800 mg BID 0 (0.0%) 24 (80.0%) 24 (66.7%)
ECOG performance status


    0 5 (83.3%) 19 (63.3%) 24 (66.7%)
    1 1 (16.7%) 11 (36.7%) 12 (33.3%)
    2 0 (0.0%) 0 (0.0%) 0 (0.0%)
Height, cm


    Median (Q1, Q3) 173.4 (171.5, 179.7) 165.1 (157.5, 172.7) 166.5 (157.5, 175.3)
    Min, Max 154.9, 185.4 151.0, 184.0 151.0, 185.4
    Missing 0 1 1
Weight, kg


    Median (Q1, Q3) 101.7 (90.9, 103.0) 83.1 (71.9, 97.5) 84.4 (71.9, 102.3)
    Min, Max 67.2, 104.0 44.5, 130.2 44.5, 130.2
    Missing 0 1 1
BMI, kg/m^2


    Median (Q1, Q3) 31.3 (29.8, 34.0) 31.0 (25.4, 34.9) 31.3 (26.1, 34.3)
    Min, Max 28.0, 34.3 19.5, 45.1 19.5, 45.1
    Missing 0 2 2
WHO-HAEM4R grade


    Grade 1 0 (0.0%) 3 (10.0%) 3 (8.3%)
    Grade 2 5 (83.3%) 10 (33.3%) 15 (41.7%)
    Grade 3A 1 (16.7%) 5 (16.7%) 6 (16.7%)
    Criteria not applicable 0 (0.0%) 12 (40.0%) 12 (33.3%)
WHO-HAEM5 classification


    Classic follicular lymphoma 6 (100.0%) 23 (76.7%) 29 (80.6%)
    Criteria not applicable 0 (0.0%) 7 (23.3%) 7 (19.4%)
Ann Arbor stage


    II 0 (0.0%) 4 (13.3%) 4 (11.1%)
    III 2 (33.3%) 15 (50.0%) 17 (47.2%)
    IV 4 (66.7%) 11 (36.7%) 15 (41.7%)
Number of GELF criteria


    1 5 (83.3%) 16 (53.3%) 21 (58.3%)
    2 1 (16.7%) 11 (36.7%) 12 (33.3%)
    3 0 (0.0%) 3 (10.0%) 3 (8.3%)
Number of FLIPI 1 risk factors


    1 0 (0.0%) 6 (23.1%) 6 (18.8%)
    2 4 (66.7%) 15 (57.7%) 19 (59.4%)
    3 1 (16.7%) 3 (11.5%) 4 (12.5%)
    4 1 (16.7%) 2 (7.7%) 3 (9.4%)
    Missing 0 4 4
Number of FLIPI 2 risk factors


    1 5 (83.3%) 14 (87.5%) 19 (86.4%)
    2 1 (16.7%) 2 (12.5%) 3 (13.6%)
    Missing 0 14 14
1 n (%)
RP2D / Phase II efficacy population is defined here as all Phase II subjects plus Phase I subjects treated at dose level 3 (800 mg twice daily). Confirm this definition before final report lock.
Continuous variables are summarized as median (Q1, Q3) and range. Categorical variables are summarized as n (%).