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NCT04680052 · OUTCOME

Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. · Source last updated 2026-09-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
up to approximately 34 months

What was measured

The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.

Analysis population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.

Groups in this outcome

FL and MZL: Tafasitamab + Rituximab + Lenalidomide

Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.

FL and MZL: Placebo + Rituximab + Lenalidomide

Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide315
FL and MZL: Placebo + Rituximab + Lenalidomide313

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide315
FL and MZL: Placebo + Rituximab + Lenalidomide313
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide72.218.78Not reportedNot reportedNot reported
FL and MZL: Placebo + Rituximab + Lenalidomide72.619.67Not reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide228
FL and MZL: Placebo + Rituximab + Lenalidomide228
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide74.218.37Not reportedNot reportedNot reported
FL and MZL: Placebo + Rituximab + Lenalidomide72.019.21Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.78
        value
        72.2
      2. group Id
        OG001
        spread
        19.67
        value
        72.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        315
      2. group Id
        OG001
        value
        313
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.37
        value
        74.2
      2. group Id
        OG001
        spread
        19.21
        value
        72.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        228
      2. group Id
        OG001
        value
        228
      units
      Participants
    title
    End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      315
    2. group Id
      OG001
      value
      313
    units
    Participants
description
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
    id
    OG000
    title
    FL and MZL: Tafasitamab + Rituximab + Lenalidomide
  2. description
    Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
    id
    OG001
    title
    FL and MZL: Placebo + Rituximab + Lenalidomide
param Type
MEAN
population Description
Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
up to approximately 34 months
title
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
type
SECONDARY
unit Of Measure
scores on a scale

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Preserved source evidence · Not medical advice