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NCT01119794 · OUTCOME

Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment

Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab · Source last updated 2015-08-26

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years

What was measured

Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only. Complete Response - CR: • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response - PR: • At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable Disease - SD: • A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease Relapsed Disease: • Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis.

Analysis population: 8/10 patients were evaluable as 2 withdrew

Groups in this outcome

Ofatumumab IV,

Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22, Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression

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

Analysis denominator · Participants

GroupSource count
Ofatumumab IV,8

Reported measurements

CR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab IV,2Not reportedNot reportedNot reportedNot reported
PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab IV,1Not reportedNot reportedNot reportedNot reported
SD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab IV,3Not reportedNot reportedNot reportedNot reported
Progression
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab IV,2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progression
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only. Complete Response - CR: • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response - PR: • At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable Disease - SD: • A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease Relapsed Disease: • Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis.
groups
  1. description
    Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22, Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression
    id
    OG000
    title
    Ofatumumab IV,
param Type
NUMBER
population Description
8/10 patients were evaluable as 2 withdrew
reporting Status
POSTED
time Frame
Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years
title
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice