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NCT00989586 · BASELINE

Baseline characteristics

Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma · Source last updated 2017-02-06

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
      18
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      35
    units
    Participants
groups
  1. description
    Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with
    id
    BG000
    title
    Phase I
  2. description
    Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
    id
    BG001
    title
    Phase II
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44
          upper Limit
          81
          value
          65
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          82
          value
          63
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          82
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    patients
population Description
Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      18
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      35
    units
    Participants
groups
  1. description
    Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with
    id
    BG000
    title
    Phase I
  2. description
    Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
    id
    BG001
    title
    Phase II
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44
          upper Limit
          81
          value
          65
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          82
          value
          63
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          82
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    patients
population Description
Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice