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NCT00722137 · OUTCOME

Duration of Response

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma · Source last updated 2018-07-12

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Median duration of follow-up of 40 months

What was measured

The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).

Analysis population: The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had \>= 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.

Groups in this outcome

R-CHOP

Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.

VcR-CAP

Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.

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

Analysis denominator · Participants

GroupSource count
R-CHOP228
VcR-CAP229

Reported measurements

Duration of response

Analysis denominator · Participants

GroupSource count
R-CHOP204
VcR-CAP211
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
R-CHOP459.0Not reported379.0518.0Not reported
VcR-CAP1110.0Not reported813.01320.0Not reported
Duration for Complete responders

Analysis denominator · Participants

GroupSource count
R-CHOP95
VcR-CAP122
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
R-CHOP563.0Not reported486.0738.0Not reported
VcR-CAP1282.0Not reported933.01602.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        379.0
        upper Limit
        518.0
        value
        459.0
      2. group Id
        OG001
        lower Limit
        813.0
        upper Limit
        1320.0
        value
        1110.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        211
      units
      Participants
    title
    Duration of response
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        486.0
        upper Limit
        738.0
        value
        563.0
      2. group Id
        OG001
        lower Limit
        933.0
        upper Limit
        1602.0
        value
        1282.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Duration for Complete responders
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      229
    units
    Participants
description
The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).
dispersion Type
95% Confidence Interval
groups
  1. description
    Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
    id
    OG000
    title
    R-CHOP
  2. description
    Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
    id
    OG001
    title
    VcR-CAP
param Type
MEDIAN
population Description
The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had \>= 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.
reporting Status
POSTED
time Frame
Median duration of follow-up of 40 months
title
Duration of Response
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice