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NCT04680052 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      273
    2. group Id
      BG001
      value
      275
    3. group Id
      BG002
      value
      53
    4. group Id
      BG003
      value
      53
    5. group Id
      BG004
      value
      654
    units
    Participants
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
    BG000
    title
    FL: Tafasitamab + Rituximab + Lenalidomide
  2. 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
    BG001
    title
    MZL: Tafasitamab + Rituximab + Lenalidomide
  3. 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
    BG002
    title
    FL: Placebo + 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
    BG003
    title
    MZL: Placebo + Rituximab + Lenalidomide
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.89
          value
          64.6
        2. group Id
          BG001
          spread
          11.69
          value
          63.7
        3. group Id
          BG002
          spread
          10.69
          value
          68.3
        4. group Id
          BG003
          spread
          11.40
          value
          67.9
        5. group Id
          BG004
          spread
          11.33
          value
          64.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          302
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          352
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          67
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          540
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          47
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          522
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          95
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          28
        title
        Not Reported
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Captured as "Other" in Database
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      273
    2. group Id
      BG001
      value
      275
    3. group Id
      BG002
      value
      53
    4. group Id
      BG003
      value
      53
    5. group Id
      BG004
      value
      654
    units
    Participants
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
    BG000
    title
    FL: Tafasitamab + Rituximab + Lenalidomide
  2. 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
    BG001
    title
    MZL: Tafasitamab + Rituximab + Lenalidomide
  3. 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
    BG002
    title
    FL: Placebo + 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
    BG003
    title
    MZL: Placebo + Rituximab + Lenalidomide
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.89
          value
          64.6
        2. group Id
          BG001
          spread
          11.69
          value
          63.7
        3. group Id
          BG002
          spread
          10.69
          value
          68.3
        4. group Id
          BG003
          spread
          11.40
          value
          67.9
        5. group Id
          BG004
          spread
          11.33
          value
          64.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          302
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          352
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          67
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          540
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          47
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          522
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          95
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          28
        title
        Not Reported
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Captured as "Other" in Database
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice