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NCT00722137 · OUTCOME

Overall Complete Response (CR + CRu)

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Median duration of follow-up of 40 months

What was measured

Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.

Analysis population: The response-evaluable population was defined as all participants who received \>= 1 dose of study drug, had at least 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

Overall complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R-CHOP95Not reportedNot reportedNot reportedNot reported
VcR-CAP122Not reportedNot reportedNot reportedNot reported
CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R-CHOP79Not reportedNot reportedNot reportedNot reported
VcR-CAP106Not reportedNot reportedNot reportedNot reported
CRu
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
R-CHOP16Not reportedNot reportedNot reportedNot reported
VcR-CAP16Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.148
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.481
    estimate Comment
    Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.007
    param Type
    Odds Ratio (OR)
    param Value
    1.688
    statistical Method
    Cochran-Mantel-Haenszel Chi-Square
Complete source fields
analyses
  1. ci Lower Limit
    1.148
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.481
    estimate Comment
    Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.007
    param Type
    Odds Ratio (OR)
    param Value
    1.688
    statistical Method
    Cochran-Mantel-Haenszel Chi-Square
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        122
    title
    Overall complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        106
    title
    CR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        16
    title
    CRu
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      229
    units
    Participants
description
Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.
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
NUMBER
population Description
The response-evaluable population was defined as all participants who received \>= 1 dose of study drug, had at least 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
Overall Complete Response (CR + CRu)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice