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NCT00811733 · OUTCOME

Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment

A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia · Source last updated 2017-05-30

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

Measure
MEDIAN
Unit
cells per microliter (µL)
Interval / dispersion
Full Range
Time frame
Baseline and Month 3

What was measured

CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Analysis population: ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.

Groups in this outcome

300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5

Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.

300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5

Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.

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

Analysis denominator · Participants

GroupSource count
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-515
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-522

Reported measurements

CD4+
Values in cells per microliter (µL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5-35.5Not reported-277194Not reported
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-598Not reported-50503Not reported
CD19+
Values in cells per microliter (µL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5-26Not reported-7340Not reported
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5-24.5Not reported-61-9Not reported
CD50
Values in cells per microliter (µL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-59Not reported-122104Not reported
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5-43Not reported-28750Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -277
        upper Limit
        194
        value
        -35.5
      2. group Id
        OG001
        lower Limit
        -50
        upper Limit
        503
        value
        98
    title
    CD4+
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -734
        upper Limit
        0
        value
        -26
      2. group Id
        OG001
        lower Limit
        -61
        upper Limit
        -9
        value
        -24.5
    title
    CD19+
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -122
        upper Limit
        104
        value
        9
      2. group Id
        OG001
        lower Limit
        -287
        upper Limit
        50
        value
        -43
    title
    CD50
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      22
    units
    Participants
description
CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
dispersion Type
Full Range
groups
  1. description
    Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
    id
    OG000
    title
    300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
  2. description
    Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
    id
    OG001
    title
    300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
param Type
MEDIAN
population Description
ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.
reporting Status
POSTED
time Frame
Baseline and Month 3
title
Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment
type
SECONDARY
unit Of Measure
cells per microliter (µL)

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

Preserved source evidence · Not medical advice