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NCT04680052 · OUTCOME

FL 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: FL Full Analysis Set. Only participants with available data were analyzed.

Groups in this outcome

FL: Tafasitamab + Rituximab + Lenalidomide

Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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: Placebo + Rituximab + Lenalidomide

Participants with FL 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.

MZL: Tafasitamab + Rituximab + Lenalidomide

Participants with marginal zone lymphoma (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.

MZL: Placebo + Rituximab + Lenalidomide

Participants with 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: Tafasitamab + Rituximab + Lenalidomide264
FL: Placebo + Rituximab + Lenalidomide264
MZL: Tafasitamab + Rituximab + Lenalidomide0
MZL: Placebo + Rituximab + Lenalidomide0

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
FL: Tafasitamab + Rituximab + Lenalidomide264
FL: Placebo + Rituximab + Lenalidomide264
MZL: Tafasitamab + Rituximab + Lenalidomide0
MZL: Placebo + Rituximab + Lenalidomide0
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide72.518.15Not reportedNot reportedNot reported
FL: Placebo + Rituximab + Lenalidomide73.619.13Not reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
FL: Tafasitamab + Rituximab + Lenalidomide186
FL: Placebo + Rituximab + Lenalidomide186
MZL: Tafasitamab + Rituximab + Lenalidomide0
MZL: Placebo + Rituximab + Lenalidomide0
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide73.718.21Not reportedNot reportedNot reported
FL: Placebo + Rituximab + Lenalidomide72.519.17Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.15
        value
        72.5
      2. group Id
        OG001
        spread
        19.13
        value
        73.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        264
      2. group Id
        OG001
        value
        264
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.21
        value
        73.7
      2. group Id
        OG001
        spread
        19.17
        value
        72.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        186
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      264
    2. group Id
      OG001
      value
      264
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    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 follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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: Tafasitamab + Rituximab + Lenalidomide
  2. description
    Participants with FL 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: Placebo + Rituximab + Lenalidomide
  3. description
    Participants with marginal zone lymphoma (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
    OG002
    title
    MZL: Tafasitamab + Rituximab + Lenalidomide
  4. description
    Participants with 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
    OG003
    title
    MZL: Placebo + Rituximab + Lenalidomide
param Type
MEAN
population Description
FL Full Analysis Set. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
up to approximately 34 months
title
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
type
SECONDARY
unit Of Measure
scores on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice